Last update 23 Jun 2024

Abaloparatide

Last update 23 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Abaloparatide (USAN/INN), Abaloparatide Acetate, Abaloparatide patch

+ [16]

Target

PTH1R

Mechanism

PTH1R agonists(Parathyroid hormone receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases

Active Indication

OsteoporosisOsteoporosis, Postmenopausal

Inactive Indication

Osteoporotic Fractures

Originator Organization

Ipsen SA

Active Organization

Theramex Ireland Ltd.

Teijin Ltd.

Radius Health, Inc.

Inactive Organization

Radius Intelligence, Inc.

Radius International, Inc.

Drug Highest PhaseApproved

First Approval Date

US (28 Apr 2017),

Osteoporosis, Postmenopausal

Regulation-

Gene Sequence

Sequence Code 164795

Source: *****

Clinical Trials associated with Abaloparatide

NCT04626141 / WithdrawnPhase 4IIT

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

Start Date01 Jun 2024

Sponsor / Collaborator

Radius Health, Inc.

NCT06154187 / Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.

Start Date01 Feb 2024

Sponsor / Collaborator

Pharmbio Korea Co., Ltd.

JPRN-UMIN000052340 / RecruitingNot ApplicableIIT

Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient - Forteo vs OSTABALO

Start Date01 Nov 2023

Sponsor / Collaborator-

100 Clinical Results associated with Abaloparatide

100 Translational Medicine associated with Abaloparatide

100 Patents (Medical) associated with Abaloparatide

330

Literatures (Medical) associated with Abaloparatide

01 Feb 2024·Journal of oral rehabilitation

Local injection of abaloparatide promotes mandibular condyle lengthening in adolescent rats via enhancing chondrogenesis and ossification

Article

Author: Fang, Jie ; Qi, Hexu ; Mei, Li ; Li, Yu ; Xu, Lin ; Li, Yuan

Abstract:

Background:

Mandibular condylar hypoplasia negatively affects patient's facial appearance and dentofacial function.

Objective:

To investigate the effect of local injection of the drug abaloparatide (ABL), an analogue of parathyroid hormone related protein (PTHrP), on promoting lengthening of the mandibular condyle.

Methods:

Thirty adolescent male Sprague–Dawley rats were randomly divided into two groups, which received the injection of ABL or normal saline (the control) every 3 days in the temporomandibular joint (TMJ) cavity. Cone‐beam computed tomography and immunohistochemistry assays were performed at 2, 4 and 6 weeks since the injection. Mandibular condylar chondrocytes (MCC) and pre‐osteoblasts were treated with ABL or PBS, followed by the CCK‐8 detection, IC50, real‐time PCR assay, Western Blot and immunofluorescence staining.

Results:

In vivo, compared with the control, the ABL group significantly increased the mandibular condylar process length (by 1.34 ± 0.59 mm at 6 weeks), the thickness of the cartilage layer, and enhanced the matrix synthesis. The ABL group had significant up‐regulation of SOX 9, COL II, PTHrP and PTH1R, down‐regulation of COL X in the cartilage, up‐regulation of RUNX 2, and unchanged osteoclastogenesis in the subchondral bone. In vitro, the intra‐TMJ injection of ABL promoted the MCC proliferation, with up‐regulated expression of chondrogenic genes, and enhanced osteogenic differentiation of the pre‐osteoblasts.

Conclusions:

Intra‐TMJ injection of abaloparatide promotes mandibular condyle lengthening in the adolescent rats via enhancing chondrogenesis in the mandibular condylar cartilage and ossification in the subchondral bone.

01 Mar 2024·Clinical therapeutics

The Safety and Efficacy of Abaloparatide on Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis

Review

Author: Wang, Yurun ; Zhu, Xinjian ; Xu, Fuxin

PURPOSE:

The aging of the population increases the incidence of postmenopausal osteoporosis, which threatens the health of elderly women. Abaloparatide is a synthetic peptide analogue of the human parathyroid hormone-related protein that has recently been approved for the treatment of postmenopausal osteoporosis. Its efficacy and safety have not been systematically evaluated. Therefore, studies on the efficacy and safety of abaloparatide could be of assistance in the clinical medication of postmenopausal osteoporosis. The aim of this study was to evaluate the clinical efficacy and safety of abaloparatide in postmenopausal osteoporosis.

METHODS:

PubMed, Cochrane Library, EMBASE, and Web of Science databases were electronically searched from inception to July 6, 2023, for relevant randomized controlled trials. Two review authors independently conducted the study screening, quality assessment (based on the Risk of Bias Assessment Tool recommended in the Cochrane handbook), and data extraction. Outcome measures included bone mineral density (BMD), bone turnover and metabolic markers, incidence of fractures, and adverse events. Data analyses were processed by using Stata SE15.

FINDINGS:

Ultimately, 8 randomized controlled trials, involving a total of 3705 postmenopausal women, were included. Meta-analysis showed that abaloparatide administration significantly increased the BMD of the lumbar vertebrae (standardized mean difference [SMD], 1.28 [95% CI, 0.81-1.76); I² = 78.5%]), femoral neck (SMD, 0.70 [95% CI, 0.17-1.23; I² = 75.7%]), and hip bone (SMD, 0.86 [95% CI, 0.53-1.20; I² = 60.4%]) in postmenopausal women compared with the control group. Type I procollagen N-terminal propeptide, a bone formation marker, was also elevated after abaloparatide administration. The incidence of vertebral fracture was lower in the abaloparatide group than in the control group (risk ratio, 0.13; 95% CI, 0.06-0.26; I² = 0%). There was no significant difference in the incidence of adverse events between the abaloparatide and the placebo groups (risk ratio, 1.03; 95% CI, 0.99-1.06; I² = 0%).

IMPLICATIONS:

Abaloparatide has a protective effect on women with postmenopausal osteoporosis. It could reduce their risk for vertebral fracture; increase their BMD of the lumbar spine, femoral neck, and hip; and alleviate symptoms and complications of postmenopausal osteoporosis with considerable safety. Limitations of this study include not searching the gray literature and not performing a subgroup analysis. PROSPERO Registration No.: CRD42022370944.

01 Jan 2024·Maturitas

Nocebo-associated treatment discontinuation with subcutaneous anti-osteoporotic drugs. A systematic review and meta-analysis of placebo-arm dropouts in randomized-controlled trials

Review

Author: Mitsikostas, Dimos D ; Anastasilakis, Athanasios D ; Sfikakis, Petros P ; Kravvariti, Evrydiki ; Diomatari, Konstantina-Maria ; Makras, Polyzois ; Kasdagli, Maria-Iosifina ; Yavropoulou, Maria P ; Kassi, Eva

OBJECTIVE:

Nocebo is a concept of therapeutics referring to unpleasant symptoms attributed by a patient to a drug, due to negative anticipation. Patients receiving oral anti-osteoporotic drugs in randomized controlled trials (RCT) can experience adverse events leading to dropout, implying that nocebo contributes to treatment discontinuation for these drugs. In this study we aim to investigate the nocebo effect of subcutaneous anti-osteoporotic drugs with a higher compliance rate than orally administered drugs.

STUDY DESIGN:

We searched MEDLINE, EMBASE, SCOPUS, and Cochrane databases for double-blind trials investigating subcutaneous anti-osteoporotic drugs for osteoporosis (namely, denosumab, teriparatide, abaloparatide and romosozumab) published up to May 2023.

MAIN OUTCOME MEASURE:

Dropouts due to reported adverse events in the placebo arms ("nocebo dropouts").

RESULTS:

Data from 17 trials were extracted. Among 10,529 placebo-treated patients the pooled nocebo-dropout percentage was 3 % for denosumab (average: 0.03; 95 % CI: 0.01-0.05), 1 % for romosozumab (average: 0.01; 95 % CI: 0.00-0.03) and 6 % for teriparatide and abaloparatide (average: 0.06; 95 % CI: 0.05-0.07). Nocebo-dropouts were significantly higher in men than women (6 % vs. 3 %, respectively, p = 0.012), in older (mean age >68 years) than in younger patients (5 % vs. 1 %, respectively, p = 0.017) and in those with more severe osteoporosis (based on the percentage of participants with prior fragility-related fractures in the study cohort) compared with patients with no prior fracture history (4 % vs. 1 %, respectively, p = 0.046).

CONCLUSION:

Nocebo responses may contribute to treatment discontinuation with subcutaneous anti-osteoporotic drugs in clinical practice. Higher nocebo-related dropout rates in the higher-risk RCT population (older patients, males, those with prior fractures) show that nocebo mechanisms have the potential to hinder therapeutic efforts to specific populations who would benefit most. Prospero registration number CRD42020212843.

News (Medical) associated with Abaloparatide

16 Apr 2024

·www.biospace.com

Radius Announces Presentation of Data on TYMLOS (abaloparatide) at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases

TYMLOS®demonstrated a lower incidence of hip fracture and non-vertebral fracture compared to teriparatide in women with osteoporosis 50 years and older (n=43,352) in this analysis of real-world data BOSTON, MA / ACCESSWIRE / April 16, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health, presented real-world evidence from an analysis comparing the effectiveness of TYMLOS® (ABL) to teriparatide (TPTD) in women with osteoporosis ages 50 years and older who were new to anabolic therapy (n=43,352). In this analysis of over 18-months of treatment, abaloparatide demonstrated a lower incidence of hip fracture and non-vertebral fracture compared to teriparatide. Hip fractures were reported in 1.1% of women in the ABL cohort and 1.4% of women in the TPTD cohort (HR [95% CI] 0.83 [0.70, 0.98]; P=0.03). Nonvertebral fractures were reported in 4.4% of women in the ABL cohort and 5.0% of women in the TPTD cohort (0.88 [0.80, 0.96]; P=0.003). Major cardiovascular events were balanced between cohorts.1 "The real-world data presented further supports the favorable efficacy and safety pro TYMLOS and why it is an important treatment option in the management of osteoporosis," said Dr. Felicia Cosman, Professor of Medicine at Columbia University College of Physicians and Surgeons in New York, NY, an osteoporosis specialist and clinical scientist and Co-Editor in Chief of the Journal Osteoporosis International. "Harnessing real-world evidence from everyday clinical settings affords clinicians the opportunity to uncover insights that can help guide treatment decisions." The data was presented in an abstract and oral presentation at the 24th Edition of the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) in London, on April 12th, 2024. This real-world retrospective observational cohort study identified women 50 years and older, newly initiated on anabolic therapy with ABL or TPTD between May 1, 2017, and Dec 31, 2021.This analysis included pre-specified outcomes and utilized propensity score matching to help balance the characteristics in each treatment group; patients were well matched on 73 baseline parameters.1 Patients were identified using anonymized claims data from the Symphony Health Patient Source, Osteoporosis Patient Transactional Datasets. This is a disease specific subset of Integrated Dataverse® which includes data from over 307 million active patients. "We are very pleased to share the results of this analysis, as it further demonstrates the value of TYMLOS in the treatment of women with osteoporosis," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to supporting men and postmenopausal women with osteoporosis, their families, and healthcare providers through our ongoing educational efforts as well as by generating data to support informed healthcare decision making." Real World Evidence: It is important to consider the limitations of RWE. RWE data sources may have incomplete information, leading to challenges in identifying and characterizing specific populations accurately. The source and type of RWE may limit the generalizability of the endpoints to broader populations/settings. RWE should be used in supplement to clinical trial evidence to support healthcare decision making. Due to data limitations, mortality data was not available in this dataset. There are no head-to-head randomized controlled clinical trials comparing abaloparatide and teriparatide. INDICATONS and IMPORTANT SAFETY INFORMATION INDICATIONS TYMLOS is indicated for: the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures, and the treatment to increase bone density in men withosteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. IMPORTANT SAFETY INFORMATION2 Contraindications: TYMLOSis contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria. Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget's disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOSmay cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOSmay cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Pregnancy and Lactation: TYMLOSis not indicated for use in females of reproductive potential. Adverse Reactions: The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%). The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%). Please see full Prescribing Information. About Abaloparatide2 Abaloparatide (TYMLOS®) was approved in April 2017 by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS® reduces the risk of vertebral fractures and nonvertebral fractures. In December 2022, Abaloparatide (TYMLOS®) was approved for the treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. Abaloparatide is supplied as a single-patient multi-use prefilled pen designed to subcutaneously administer 80 micrograms per dose over a 30-day period. About Radius: Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also recently announced an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health. Reginster JY, et al. The comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: update of a real-world retrospective analysis. Presented at the WCO-IOF-ESCEO Annual Meeting, April 11-14, 2024 in London, UK. Accessed April 10, 2024. TYMLOS® [prescribing information]. Boston, MA: Radius Health, Inc. TYMLOS® Medication Guide. Radius Health, Inc.; Boston, MA. Contact: Sara Goldberg: Head of Communications Email: corporatecommunications@radiuspharm.com Phone: +1 (631) 379-8374 SOURCE: Radius Health, Inc. View the original press release on accesswire.com

Clinical ResultDrug ApprovalLicense out/inClinical Study

21 Jan 2024

·medcitynews.com

Amgen Osteoporosis Drug Prolia Is Hit With FDA’s Strictest Warning

A blockbuster Amgen drug for osteoporosis now carries the FDA’s strictest warning that its use can lead to dangerously low levels of calcium in the blood. This complication, hypocalcemia, is a particular risk for patients with advanced kidney disease, the black box warning states. In these patients, this adverse effect resulted in hospitalization, life-threatening events, and in some cases death. Severe hypocalcemia can be asymptomatic but symptoms the FDA warned that patients and physicians should watch for include confusion, irregular heart rhythm, fainting, muscle spasms, and weakness. Prolia, a monoclonal antibody administered every six months as a subcutaneous injection, was first approved in 2010 as a treatment for osteoporosis in postmenopausal women at high risk of fracture. The drug works by binding to a protein key to the function and survival of cells involved in the natural process in which bone is broken down and absorbed by the body. Reducing this bone resorption is intended to increase bone mass and strength. While the black box warning is new, the hypocalcemia risk is not. This complication was among those listed on the drug’s original label. Approval of Prolia came with a Risk Evaluation and Mitigation Strategy, an FDA program that imposes strict oversight of a drug to guard against safety problems. The FDA also required Amgen to conduct additional clinical testing to further assess safety. In 2022, the FDA issued an alert stating it is investigating the risk that Prolia may cause severe hypocalcemia in patients with advanced kidney disease that requires dialysis treatment. That alert stemmed from the ongoing review of Amgen’s longer-term testing of its osteoporosis drug. The black box warning comes after an FDA review of Centers for Medicare & Medicaid Services studies found that treatment with Prolia led to a significant increase in the risk of developing severe hypocalcemia compared to bisphosphonates, an older class of osteoporosis drugs. The FDA said the complication typically developed two to 10 weeks following each Prolia injection, with the greatest risk during weeks two to five. The agency also reviewed 25 cases submitted through the FDA Adverse Event Report System database. The FDA said patients taking Prolia should maintain adequate calcium and vitamin D intake. For those with advanced kidney disease, the FDA advises frequent monitoring of calcium levels in the blood. The FDA also said clinicians should consider Prolia’s hypocalcemia risk in the context of other osteoporosis drugs available. Last year, Prolia accounted for $2.9 billion in revenue in the nine months ending Sept. 30, according to Amgen’s most recent financial report. Amgen also sells a newer osteoporosis drug called Evenity, though hypocalcemia has also been reported in patients treated with this product. Alternative osteoporosis therapies include Eli Lilly’s Forteo and Tymlos from Radius Health. The labels of all of these products carry black box warnings that flag various safety risks. Here’s a recap of other recent regulatory news: —Vertex Pharmaceuticals gene therapy Casgevy landed FDA approval as a treatment for the rare blood disease beta thalassemia. This approval comes about six weeks after the agency first approved the therapy as a treatment for sickle cell disease. Vertex set a $2.2 million price for the one-time therapy, the same price it charges in the sickle cell disease indication. It will compete against Bluebird Bio’s Zynteglo, the $2.8 million gene therapy approved in 2022 for treating beta thalassemia. —Authorities in Japan approved AstraZeneca drug danicopan as a new treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder in which the complement system attacks red blood cells. The oral drug will be marketed under the brand name Voydeya. AstraZeneca already markets the PNH drugs Soliris and Ultomiris, both of which work by blocking a complement system protein called C5. Voydeya addresses a different protein called factor D. Japanese authorities approved Voydeya as an add-on therapy for patients whose disease is not sufficiently addressed by a C5 inhibitor. The approval is the first anywhere in the world for this drug. —The European Commission approved a subcutaneously injected version of Roche cancer immunotherapy Tecentriq. The drug, which blocks the checkpoint protein PD-L1 on cancer cells, has been available as an intravenous infusion that takes between 30 and 60 minutes. Roche said the subcutaneous version will take between four and eight minutes. —The FDA turned down Satsuma Pharmaceuticals’ drug/device combination treatment for migraine, citing manufacturing issues, Satsuma parent company Shin Nippon Biomedical Laboratories announced. Satsuma’s product candidate, STS101, is a dry powder formulation of the old migraine drug dihydroergotamine. It’s administered via an intranasal device intended to bring patients faster pain relief. The FDA complete response letter is the latest in a string of setbacks for Satsuma. In 2020, STS101 failed a Phase 3 clinical trial. Analysis of the trial data found problems with the device and the way patients were using it. Satsuma modified the device and ran another Phase 3 study. —Manufacturing issues were also to blame for the FDA rejection of zolbetuximab, an Astellas Pharma drug developed for treating gastric or gastroesophageal junction adenocarcinoma. The antibody drug is at the front of a competitive pack of drug candidates designed to target claudin 18.2, a protein abundant on cancerous stomach cells. Photo by FDA

Drug ApprovalPhase 3Immunotherapy

09 Jan 2023

·www.biopharmadive.com

5 FDA decisions to watch in the first quarter

The downturn that struck the biotechnology industry in 2022 wasnt just about tumbling stock prices. The sector also won only 37 new drug approvals from the Food and Drug Administrations main review office last year, its lowest total since 2016.Yet the number of drugs the FDA clears each year can fluctuate, and industry observers see reasons for optimism. The 2022 approvals of Amylyx Pharmaceuticals ALS drug and Provention Bios Type 1 diabetes treatment show an increasing permissiveness for drugs with mixed or limited data, RBC Capital Markets analysts wrote in December. Drug rejections and FDA-mandated trial stoppages were down compared to 2021. The regulator also cleared three gene therapies for inherited diseases, a sign that Commissioner Robert Califf seems open to innovation, they wrote.That sentiment could be put to the test early in 2023. The FDA is weighing decisions on another drug for Alzheimers as well as a gene therapy for hemophilia A.Here are five decisions to watch in the first quarter:Eli Lillys donanemab for Alzheimers diseaseEisai and Biogens Alzheimers drug Leqembi, which U.S. regulators conditionally cleared last week, could soon have company. Following closely behind it is donanemab, a similarly acting drug from Eli Lilly that could reach market sometime within the next two months.An accelerated approval for donanemab would give Lilly something to show for the many years its invested in Alzheimers research. But the company may face an uphill battle winning market share, at least in the near-term.Leqembi has already been shown to slow disease progression in a large Phase 3 trial, albeit modestly. Donanemabs application, by comparison, is largely based on results from smaller mid-stage studies. Late-stage data are expected toward the middle of the year, potentially months after the drug is available.In the meantime, doctors could have tough decisions to make about which drug to prescribe and Lilly may have to tread carefully in choosing a price. Biogen ran into fierce resistance from insurers when it priced its earlier Alzheimers drug, Aduhelm, at $56,000 a year despite mixed results in clinical testing. Eisai chose a lower price of $26,500 a year for Leqembi, setting a new bar.Until the FDA grants a full clearance, however, neither Leqembi nor donanemab, if approved, are likely to see much use under restrictive coverage rules put in place by Medicare. Jonathan GardnerMenarini Groups elacestrant for breast cancerBefore being acquired last year by two private equity firms, biotech company Radius Health was primarily known for an osteoporosis drug called Tymlos that it struggled to sell. Its second act, a breast cancer medicine called elacestrant, may have a better chance at commercial success.Elacestrant is one of a group of medicines, known as SERDs for short, that block and degrade hormone receptor proteins and are administered as pills. The hope is these drugs could replace fulvestrant, an injectable medicine thats widely prescribed for breast cancer patients whose disease is driven by hormones. Yet their prospects are unclear. Only elacestrant has succeeded in a pivotal trial. Two similar drugs from Roche and Sanofi failed.An approval by the FDAs Feb. 17 deadline could give the Italian pharmaceutical company Menarini Group, which licensed elacestrant from Radius in 2020, the first crack at a potentially substantial market. Menarini is seeking approval of the drug for patients with an advanced, common form of breast cancer known as ER-positive, HER2-negative. Elacestrant would be the first branded endocrine therapy for this patient group in more than two decades.Analysts at Stifel, citing discussions with breast cancer experts in a December research note, said adoption in the second-line setting could be strong if the drug is approved. But that could depend on the price Menarini chooses, and whether the FDA approves it for all patients, or only the subset who appear to benefit the most, they wrote.Menarini may not have the market to itself for long, either. AstraZeneca, Lilly and Arvinas each have rival medicines in advanced testing. Ben FidlerBioMarin Pharmaceuticals Roctavian for hemophilia A2023 could be the year BioMarin finally brings Roctavian, its gene therapy for hemophilia A, to market in the U.S. But BioMarin may still have one more obstacle to overcome on its already lengthy journey to an FDA approval.BioMarin has spent years developing Roctavian for hemophilia A, the most common form of the chronic blood disease and a condition caused by a lack of a clotting protein. Like Hemgenix, the hemophilia B gene therapy the FDA approved in November, Roctavian is meant to be a long-lasting treatment that boosts levels of clotting protein, protecting patients from spontaneous bleeds and ridding them of the need to take other drugs. Its shown the ability to do so in clinical testing, but also signs that its benefits may wane with time.BioMarins data has been enough to sway European regulators, which approved Roctavian last August. Yet the company has had a tougher time convincing the FDA. The agency rejected Roctavian in 2020, asking for more data on how the treatments effects held up. BioMarin subsequently collected those data and filed a new application. But the company recently signaled even that review may extend beyond its March 31 deadline as the FDA analyzes full three-year results from Roctavians main trial, which were released on Sunday.Despite the lingering uncertainty, analysts are generally optimistic. The approval of Hemgenix shows the FDA appear[s] to be more comfortable with hemophilia gene therapies, SVB Securities analysts wrote in December. RBC analysts also noted in December that the agency had reversed an earlier decision to hold an advisory committee meeting, removing a potential hurdle.An approval would keep BioMarin ahead of Pfizer and Roche, which are also developing hemophilia A gene therapies. Delilah AlvaradoAcadia Pharmaceuticals trofinetide for Rett syndromeTwice now, the FDA has turned back attempts by Acadia to secure an expanded approval for a Parkinsons disease drug it sells as Nuplazid. In April 2021 and again last August, the agency rejected the companys applications to extend use of Nuplazid to treat psychosis related to dementia.Acadias regulatory difficulties have weighed on the company, as shares have sunk by nearly two-thirds since the initial signs trouble with the first application.But the company is hoping for a different outcome with its drug trofinetide, which it has been developing for a neurodevelopmental disorder called Rett syndrome. Its application is now under review by the FDA, with a target decision date of March 12.In clinical testing, treatment with trofinetide improved scores on two assessments of Rett syndrome symptoms compared to placebo among girls and young women with the disorder.If approved, trofinetide would become the first treatment for Rett, giving patients a needed option. For Acadia, success would also be a boon, potentially offsetting struggles the company has had selling Nuplazid in its approved Parkinsons disease indication. An approval could also come with a special regulatory voucher that can be resold.Acadia acquired North American rights to trofinetide in a 2018 deal with Neuren Pharmaceuticals. If the drug is approved and the FDA issues a voucher, Neuren would be due one-third of its value. Ned PagliaruloGilead Sciences Trodelvy for breast cancerGilead is best known for its HIV and hepatitis C medicines, two highly lucrative businesses that were catalyzed by acquisitions.The California biotech has hopes for similar success with its $21 billion purchase of Immunomedics two-plus years ago, the largest acquisition in the companys history. The deal brought in a cancer drug called Trodelvy that Gilead views as the linchpin in its push into oncology, a field of research the company historically hasnt taken part in.But, so far, analysts arent convinced the deal was worth its high price. Trodelvy is currently approved for a tough-to-treat triple-negative form of breast cancer. Broadening its use into the most common form of breast cancer, known as HR-positive and HER2-negative, could help boost its prospects.Initial results from an important clinical trial were positive, but viewed as showing only a modest benefit. Follow-up data revealed treatment led to three months longer survival.The FDA is currently reviewing Gileads request to expand Todelvys approval to cover use in this setting, for adults with previously treated locally advanced or metastatic breast cancer that cant be removed surgically. A decision is due in February.Even if an approval is granted, Gilead faces tough competition from another breast cancer drug called Enhertu. Developed by AstraZeneca and Daiichi Sankyo, Enhertu has shown strong results in testing and was recently approved by the FDA for use in treating cancers that are considered to be HER2 low.Analysts currently expect Trodelvy would be used after Enhertu in this kind of breast cancer. Ned Pagliarulo '

Drug ApprovalClinical ResultPhase 3AcquisitionAccelerated Approval

100 Deals associated with Abaloparatide

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D10885	Abaloparatide	H05AA	DB05084

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis	JP	Teijin Ltd.	31 Aug 2022
Osteoporosis, Postmenopausal	US	Radius Health, Inc.	28 Apr 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporotic Fractures	Phase 3	US	Radius Health, Inc.	20 Sep 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	dyclivslmc(qhvijcsunv) = jrktsvlhog kdvhtqyhpu (oitvfsucyj ) View more	Positive	16 Apr 2024
				Teriparatide	dyclivslmc(qhvijcsunv) = gvnyowjadh kdvhtqyhpu (oitvfsucyj ) View more
NCT04366726 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	22	abaloparatide-sMTS	lciliwpqbd(ydbrwacbtq) = cuxlivpfcl fpqmeysxhh (qkrdmcnmwv, tceiubamfv - njhyrsbdum) View more	-	22 Nov 2023
NCT03512262 (ATOM, CTgov)	Phase 3	Osteoporosis	228	Abaloparatide (Abaloparatide)	hmilmirivg(gaabdbhdpz) = oxrlbwptij hygmkhuell (zjhbyecltp, fcalmdjvwo - gtowjfjmbc) View more	-	07 Apr 2023
				Placebo (Placebo)	hmilmirivg(gaabdbhdpz) = yoloypswiu hygmkhuell (zjhbyecltp, bpvqtaskmt - npglqnmxyo) View more
NCT04064411 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	511	abaloparatide (Abaloparatide-SC)	fkkbcmioto(xjytzkqsjs) = edteszutvb vaiymchzhe (dljbnlsmho, qixrfghyvq - zucaevkmmf) View more	-	15 Feb 2023
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	fkkbcmioto(xjytzkqsjs) = aoezeirfgs vaiymchzhe (dljbnlsmho, htplkulucv - jxafmehrzs) View more
NCT03512262 (ATOM, GlobeNewswire) Manual	Phase 3	Osteoporosis	228	Abaloparatide	znvbpwdpfv(rzieoasvnq) = ovrzmhislw hzjenjwsen (jxmzugsdjr )	Positive	18 Oct 2021
				Placebo	znvbpwdpfv(rzieoasvnq) = aznebwlbxr hzjenjwsen (jxmzugsdjr )
NCT03710889 (CTgov)	Phase 3	Osteoporosis, Postmenopausal \| Osteoporotic Fractures	23	Abaloparatide	hyajdgasyc(ezbbinqobq) = jsmwqmeonk faaxtvvcmi (fccrottuwr, mpjyzvwvgx - xtkquxykwb) View more	-	15 Oct 2021
NCT04366726 (Pubmed \| Clin Drug Investig)	Phase 1	Bone Diseases, Metabolic	22	Abaloparatide-sMTS 300 μg	xloltbnqqi(svypehwslg) = frybpecoqq ancayldala (kttrgdolzo ) View more	-	27 Feb 2021
NCT01343004 \| NCT01657162 (Pubmed \| J Clin Endocrinol Metab)	Phase 3	Osteoporosis, Postmenopausal	-	Abaloparatide	wlqhjzxwov(bkhxywhgpe) = htanlibvab jsqpeloipu (guzbqbwbfq )	-	01 Mar 2020
				Alendronate	wlqhjzxwov(bkhxywhgpe) = rgfztocbwp jsqpeloipu (guzbqbwbfq )
ACR2017	Not Applicable	Glucocorticoid-induced osteoporosis	32	Abaloparatide 5 μg/kg	fpodlellmv(rynghoxapw) = ncioftazap ojzawdrkqk (rvxzbxjnto )	Positive	07 Nov 2017
NCT01343004 (ACTIVE, CTgov)	Phase 3	Osteoporosis, Postmenopausal \| Fractures, Bone	2,463	Placebo (Placebo)	wquzwjpwur(rkisfrpmbm) = icsyqzeves uqwpkrgxze (vpnwkfhaqy, uaknqpbjso - hxojsmyrjw) View more	-	01 Mar 2017
				BA058 80 mcg (BA058 80 mcg (Abaloparatide))	wquzwjpwur(rkisfrpmbm) = ugoqffypvx uqwpkrgxze (vpnwkfhaqy, fyxmdypypo - qogqhjjtnq) View more

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