Delving into the Latest Updates on Fulranumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Fulranumab (USAN/INN), AMG-403, JNJ-42160443

Target

NGF

Action

inhibitors

Mechanism

NGF inhibitors(Nerve growth factor inhibitors)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesSkin and Musculoskeletal Diseases+ [3]

Active Indication-

Inactive Indication

ArthralgiaBladder painCancer Pain+ [11]

Originator Organization

Janssen Global Services LLC

Active Organization-

Inactive Organization

Johnson & Johnson Pharmaceutical Research & Development LLC

Amgen, Inc.Janssen Research & Development LLC

+ [1]

License Organization

Amgen, Inc.

Janssen Pharmaceuticals, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 51842H

Source: *****

Sequence Code 51871L

Source: *****

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is not adequately controlled by current pain therapy.

Start Date07 Jul 2015

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Fulranumab

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100 Translational Medicine associated with Fulranumab

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100 Patents (Medical) associated with Fulranumab

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22

Literatures (Medical) associated with Fulranumab

01 Apr 2025·CLINICAL RHEUMATOLOGY

Standardized efficacy and safety evaluation of fulranumab for osteoarthritis

Review

Author: Kou, Haiyang ; Chen, Bo

To assess the impact of fulranumab intervention on osteoarthritis (OA) patients and offer a clinically relevant, evidence-based guide for fulranumab intervention in patients with OA. RevMan 5.4 was utilized to conduct a meta-analysis after relevant data on randomized controlled trials of therapeutic interventions for patients with OA were gathered from literature databases such PubMed, Embase, Web of Science, and the Cochrane Library. A total of 8 randomized controlled studies were included, including 1927 patients with osteoarthritis. Meta-analysis showed that compared with the control group, fulranumab intervention had more gains, (MD = - 6.76, 95% CI [- 13.37 to - 0.15]; Z = 2.00; P = 0.05), WOMAC pain (3 mg, week 17) (MD = - 0.78, 95% CI [- 1.10 to - 0.46]; Z = 4.79; P < 0.00001), BPI-SF: pain intensity score (1 mg, week 12) (MD = - 4.29, 95% CI [- 9.15 to 0.57]; Z = 1.73; P = 0.08), and BPI-SF: pain interference (1 mg, week 12) (MD = - 5.98, 95% CI [- 6.64 to - 5.32]; Z = 17.84; P < 0.00001). When used in conjunction with nerve growth factor (NGF) therapy, fulranumab offers an efficient osteoarthritis therapeutic alternative. Patients with osteoarthritis can have a considerable improvement in their WOMAC, short pain inventory, patient global assessment scores, clinical symptoms, and overall quality of life. One possible therapeutic approach for the condition might be to use fulranumab.

02 Dec 2019·Current medical research and opinionQ4 · MEDICINE

Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies

Q4 · MEDICINE

Article

Author: Sanga, Panna ; Haeussler, Juergen ; Zaki, Naim ; Thipphawong, John ; Louie, John ; Wang, Steven ; Kelly, Kathleen M.

Objective: To evaluate the safety and efficacy of fulranumab as adjunct or monotherapy in patients with knee or hip pain related to moderate-to-severe osteoarthritis.Methods: Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. Safety assessments included treatment-emergent adverse events (TEAEs), and neurological, sympathetic, and joint-related events of interest. Efficacy assessments included pain and physical function sub-scales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.Results: Of 245 patients from the ITT set (median age = 64 years; 62% women), 84 (34%) completed the DB phase; the majority of discontinuations (57%) were due to early study termination. In the DB phase, the incidence of TEAEs in fulranumab 3 mg (57.8%) and 1 mg (56.8%) was similar to placebo (56.8%). Two events adjudicated as joint-related events of interest include rapidly progressive osteoarthritis and fracture of unknown etiology. There were no new neurological TEAEs. Fulranumab showed evidence of efficacy in improving pain and physical function based on WOMAC sub-scale scores. Due to premature study termination, the number of patients enrolled were too small to make any definitive efficacy claims.Conclusions: Treatment with fulranumab was generally tolerated with no new safety signals. Within the limited sample analyzed, fulranumab showed evidence of improvement of pain and function in patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery.Clinical trial registration numbers: NCT02336685; NCT02336698; NCT02289716; NCT02301234KEY POINTSFulranumab as adjuvant or monotherapy was well tolerated with no new safety signalsFulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and kneeFulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.

01 May 2019·International journal of toxicologyQ4 · MEDICINE

Evaluation of the Toxicity and Neurological Effects of Fulranumab in Adult Cynomolgus Monkeys

Q4 · MEDICINE

Article

Author: Rocca, Meredith ; Coogan, Timothy P. ; Han, Chao ; Butt, Mark

Fulranumab, an anti-human nerve growth factor antibody, was evaluated in a series of nonclinical toxicology studies. No treatment effects were observed in adolescent cynomolgus monkeys in standard design, repeat-dose toxicology studies of up to 6 months. Adverse effects on the developing nervous system were observed in offspring of pregnant cynomolgus monkeys treated with fulranumab. Subsequent studies including detailed morphologic investigations of the nervous system did reveal fulranumab-related changes in adult cynomolgus monkeys; this article is focused on those findings. A single dose of ≥1 mg/kg fulranumab administered subcutaneously (SC) caused a decrease in neuron and sympathetic ganglion size (superior cervical ganglion), observed morphologically and stereologically, with a resulting appearance of increased glial cell density. Similar results were observed in repeat-dose (15 to 52 weeks) toxicity studies at ≤50 mg/kg/wk fulranumab SC. These effects recovered after a 3-month treatment-free period. Fulranumab did not cause any neuronal death, necrosis, apoptosis, or any apparent decrease in function of sympathetic neurons/ganglia at any time point examined. A no observed effect level (NOEL) was established at 0.25 mg/kg fulranumab SC every 4 weeks for 28 weeks.

2

News (Medical) associated with Fulranumab

24 Jun 2016

·www.biospace.com

Takeda Returns Certain Molecules, Products to Amgen

June 24, 2016 By Alex Keown , BioSpace.com Breaking News Staff OSAKA, Japan – Takeda Pharmaceutical Company announced this morning that it was returning some molecules and products to Amgen it had access to through a collaboration agreement that yielded a cancer treatment for the Japanese market. Takeda and Amgen struck a deal to develop and commercialize multiple molecules and products that belong to Amgen’s pipeline for commercialization in Japan. Among the molecules being returned to Amgen are AMG403, for the treatment of pain related to cancer, and AMG386, an anti-angiopoietin peptibody for the treatment of solid tumors in various types of cancer. The company did not specify why it was returning the molecules to Amgen, only saying it looked forward to future collaboration on other molecules that remained within its keeping. Those molecules being returned will be done immediately, Takeda said. Amgen and Takeda struck its struck its collaboration deal in 2008 for 13 molecules from Amgen’s pipeline. At the time the deal was struck, the pipeline included early to mid-stage clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation and pain. The Amgen / Takeda deal included the colorectal cancer drug Vectibix, which Takeda was able to bring to the Japanese market in 2010. “Through our work with Amgen, we have successfully delivered Vectibix to the Japanese patients facing a challenging diagnosis while continuing to build our scientific understanding of novel treatment pathways,” Phil Rowlands , interim head of Takeda’s oncology therapeutic unit. “We look forward to continuing our scientific discovery and to building a portfolio of innovative medicines through our ongoing collaboration with Amgen.” Takeda said it will work with Amgen to ensure a smooth transition of the return of the molecules and will cooperate with Amgen to ensure patients will receive appropriate therapies in Japan. This is not the first time this year that Takeda has returned some experimental products in its pipeline to the parent companies. Earlier this year, Takeda returned the U.S. rights to the anti-obesity drug Contrave to its partner Orexigen . Takeda said the move will allow the company to focus on its inflammatory bowel disease drugs, gout, diabetes and its products for major depressive disorder. In addition to recently returning those drug molecules, Takeda also recently created two new business units to support its pipeline. A dedicated Specialty Business Unit will enable Takeda to develop best-in-class capabilities in areas such as patient support and evidence generation. Takeda’s new General Medicine Business Unit will support marketing operations for the company pipeline. Shares of Takeda, which trades on the Tokyo Stock Exchange , are down more than 7 percent this morning.

License out/in

01 Apr 2016

·www.biospace.com

Janssen R&D Discontinues Fulranumab Phase III Program; Terminates Agreement with Amgen

April 1, 2016 By Alex Keown , BioSpace.com Breaking News Staff TITUSVILLE, N.J. -- Janssen Research & Development , a subsidiary of Johnson & Johnson , terminated its Phase III development program for fulranumab in osteoarthritis pain due to a “strategic portfolio prioritization,” the company announced late Thursday. Janssen had been developing the drug through a licensing agreement with Amgen, Inc. With its abandonment of the project, Janssen said it is returning all program rights back to Amgen. Fulranumab is part of an experimental class of non-opioid biological medicines called anti-nerve growth factor compounds. Those drug compounds had been placed on a hold by the U.S. Food and Drug Administration (FDA) in 2011 due to heightened risk of joint damage, Seeking Alpha noted. The FDA’s hold has been lifted. Janssen said their reasons for terminating the agreement had nothing to do with safety concerns. The neuroscience therapeutic area of Janssen will continue to pursue discovery and development programs in Alzheimer’s disease and serious mental illness, the company said. In 2008, Amgen Inc. licensed fulranumab to Ortho-McNeil-Janssen Pharmaceuticals, Inc. , now known as Janssen Pharmaceuticals, Inc. Janssen’s development of fulranumab could have generated about $435 million annually for Amgen, Genengnews.com reported. Janssen’s new 2020 strategy was designed to turn the company into “a transformational medical innovator,” with a focus on the development of innovative therapeutic solutions. Areas of therapeutic focus include cardiovascular and metabolic diseases, immunology, infectious diseases and vaccines, neuroscience, and oncology according to Janssen’s website. Fulranumab was included in Janssen’s 2015 list of new drugs that had the potential to become blockbuster treatments by 2019, earning more than $1 billion in annual sales. Other drugs the company included in that list are daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C. Takeda Pharmaceuticals currently holds the rights to fulranumab in Japan. The Japanese company licensed the rights to the drug from Amgen in 2008. The drug is currently in a Phase I trial for pain, according to Takeda’s website. In March, Janssen Research & Development struck a deal with Genentech to initiate two studies to determine the safety and tolerability of daratumumab (Darzalex) and atezolizumab for treatment of in multiple myeloma and in solid tumor.

License out/inPhase 1Phase 3Drug ApprovalPhase 2

100 Deals associated with Fulranumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D09907	Fulranumab	-	DB12102

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	United States	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Australia	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Canada	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Czechia	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Germany	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Hungary	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Poland	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	South Korea	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Spain	Janssen Research & Development LLC	25 Mar 2015
Osteoarthritis, Knee	Phase 3	Sweden	Janssen Research & Development LLC	25 Mar 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00964990 (Pubmed \| Clin J Pain) Manual	Phase 2	Neuralgia, Postherpetic \| Peripheral Nervous System Diseases	34	Fulranumab	mqggptzery(ggbzgjypxo) = There was no significant difference rydludubxr (gvtcjbtnas ) View more	Negative	01 Feb 2017
				Placebo
NCT01060254 (Pubmed \| BMC Urol) Manual	Phase 2	Cystitis, Interstitial	31	Fulranumab	ruzyrjwkah(zcconsoiii) = fvchhaemqw qcenlvhltj (etkqcxhjgs )	Negative	05 Jan 2017
				Placebo	ruzyrjwkah(zcconsoiii) = zibljmhwbm qcenlvhltj (etkqcxhjgs )
NCT00973024 (Pubmed \| Med Lett Drugs Ther \| Clin Ther) Manual	Phase 2	Low Back Pain	385	Fulranumab	tgjhxaqpxw(csgubeppcj) = tmlszvreuf pevzmrvhek (fozyglrvnp, 2.18) View more	Negative	01 Jun 2016
				Placebo	muzgbgheau(spnvokuglm) = uuzvbvjsni qprctfbfcm (jntnnxuvff ) View more
NCT01094262 (Pubmed \| Int J Clin Pract)	Phase 2	-	196	Placebo	icnralveaz(mbwizqylrt) = qiqfahryde eyzjijgamq (gthuglpbzw )	Positive	01 Jun 2016
				Fulranumab 3mg every 4 weeks	icnralveaz(mbwizqylrt) = ouevkqngtd eyzjijgamq (gthuglpbzw )
AAN2013	Phase 2	Diabetic peripheral neuropathic pain nerve growth factor (NGF)	77	Placebo	xezfqbuudi(oxqzgpyhlr) = trkpywzxew ilxxoeuyew (sgiuaejtuo )	Positive	12 Feb 2013
				Fulranumab 1 mg	xezfqbuudi(oxqzgpyhlr) = tbjpzonxwr ilxxoeuyew (sgiuaejtuo )

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Fulranumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation