Delving into the Latest Updates on Eptinezumab-JJMR with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Eptinezumab, ALD-403, LU AG09221

+ [1]

Target

CGRP

Mechanism

CGRP antagonists(Calcitonin gene-related peptide antagonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Migraine DisordersHeadache Disorders, SecondaryCluster Headache

Inactive Indication

Headache caused by drug

Originator Organization

H. Lundbeck A/S

Active Organization

H. Lundbeck A/SLundbeck Canada Inc.

Lundbeck Seattle BioPharmaceuticals, Inc.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (21 Feb 2020),

Migraine Disorders

Regulation-

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Gene Sequence

Sequence Code 156338L

Source: *****

Sequence Code 201708H

Source: *****

The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.
Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.
Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.
This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.

Start Date30 Sep 2024

Sponsor / Collaborator

Healthtech Connex, Inc.

[+3]

NCT05937152 / RecruitingPhase 2

CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial

The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).

Start Date01 Jun 2024

Sponsor / Collaborator

Mayo Clinic

NCT06409845 / RecruitingNot ApplicableIIT

Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Start Date26 Mar 2024

Sponsor / Collaborator

University of Florence

[+8]

100 Clinical Results associated with Eptinezumab-JJMR

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100 Translational Medicine associated with Eptinezumab-JJMR

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100 Patents (Medical) associated with Eptinezumab-JJMR

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166

Literatures (Medical) associated with Eptinezumab-JJMR

29 Feb 2024·Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology

Efficacy and Safety of Anti-CGRP Monoclonal Antibodies in Prevention of Chronic Migraine: A Bayesian Network Meta-analysis

Review

Author: Haridas, Mundot Puliappadamb ; Srinivasan, Anand ; Maiti, Rituparna ; Tripathy, Amruta

Due to the unmet needs in the management of migraine, a primary headache, and disabling disorder, the past decade has focused on developing monoclonal antibodies (mAbs) against the calcitonin-gene-related peptide (CGRP) as migraine prophylactic agents. The objective of the study was to evaluate the efficacy and safety of various anti-CGRP mAbs in the prevention of chronic migraine. Network meta-analysis (NMA) was performed using the Bayesian framework to estimate the efficacy and safety of mAbs after performing a literature search in PubMed, MEDLINE, Cochrane database, and International Clinical Trial Registry Platform (ICTRP). The outcomes calculated were in terms of mean difference (MD) or odds ratio (OR) with a 95% credible interval (95%CrI). Network graphs were constructed and node-split analysis was done to analyze the inconsistency. The NMA included a total of 10 clinical trials. Galacanezumab (120 mg) (MD: -2.7; 95%CrI: -4.8 to -0.83) was found to be better than other mAbs in terms of the difference in mean migraine days (MMD). Fremanezumab quarterly dose administration showed the best response (OR: 2.9; 95%CrI: 1.9 to 4.6) in terms of responder rate. Eptinezumab was found to be safer (OR: 0.88; 95%CrI: 0.61-1.3) as compared to other mAbs in terms of the rate of adverse events. Fremanezumab (quarterly) ranked better in terms of response rate, and eptinezumab was found to be the safest in the prophylactic management of migraine. Galacenequmab was better at reducing MMD. Further studies are needed to evaluate the long-term safety, efficacy, and use of mAbs in migraine patients.

01 Feb 2024·European journal of neurology

Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: post hoc analysis of the DELIVER randomized clinical trial

Article

Author: Lipton, Richard B ; Mitsikostas, Dimos D ; Ashina, Messoud ; Versijpt, Jan ; Christoffersen, Cecilie Laurberg ; Ettrup, Anders ; Sperling, Bjørn ; Sacco, Simona ; Ailani, Jessica

Abstract:

Background and purpose:

Eptinezumab reduced monthly migraine days more than placebo in the DELIVER study, a clinical trial with patients with difficult‐to‐treat migraine and prior preventive treatment failures. This post hoc analysis assesses the sustained response to eptinezumab at the population and patient level and evaluates the potential for response in initial non‐responders.

Methods:

Adults with chronic or episodic migraine and two to four prior preventive treatment failures were randomized to eptinezumab 100 mg, 300 mg or placebo every 12 weeks. Primary outcomes in this post hoc analysis are the proportion of patients with ≥30%, ≥50% or ≥75% reduction in monthly migraine days (i.e., migraine responder rates [MRRs]) during weeks 1–12 and weeks 13–24 and across 4‐week intervals. Secondary outcomes are maintenance and shifts in MRRs from weeks 1–12 to weeks 13–24.

Results:

Between weeks 1–12 and 13–24, ≥30% MRRs increased from 65.9% to 70.4% (100 mg) and from 71.0% to 74.5% (300 mg), versus 36.9% to 43.1% (placebo). The ≥50% and ≥75% MRRs were sustained or increased over the 24‐week period. The largest increase in ≥30% MRRs occurred after the second infusion with eptinezumab. The percentage of initial non‐responders (<30% MRRs during weeks 1–12) who experienced response (≥30% MRRs during weeks 13–24) to the second dose was 34.7% (100 mg) and 30.4% (300 mg) with eptinezumab versus 21.1% with placebo.

Conclusion:

Across MRR thresholds, most patients who responded to eptinezumab during weeks 1–12 maintained or improved response during weeks 13–24. More than one‐third of initial non‐responders became responders after their second infusion.

01 Jan 2024·Handbook of clinical neurology

CGRP monoclonal antibodies and CGRP receptor antagonists (Gepants) in migraine prevention

Review

Author: Alpuente, Alicia ; Pozo-Rosich, Patricia ; Caronna, Edoardo ; Torres-Ferrus, Marta

Migraine is a prevalent and disabling neurological disease. Its preventive treatment for decades has been rather limited due to the absence of disease-specific therapies with limited efficacy and tolerability. The advances made in migraine research have led to the discovery of the calcitonin gene-related peptide (CGRP) and its role in migraine pathophysiology. CGRP is a neuropeptide that acts as potent vasodilator and is involved in pain processing. Increased levels of plasma CGRP have been observed during migraine attacks as well as interictally when comparing patients with migraine and healthy controls. In the last years, two classes of drugs antagonizing CGRP have therefore been developed as the first migraine-specific preventive treatments: anti-CGRP monoclonal antibodies (mAbs) and gepants. Four mAbs have been approved: erenumab, galcanezumab, fremanezumab, and eptinezumab. Gepants are small molecules that antagonize the CGRP receptor; currently only rimegepant and atogepant have been approved for migraine prevention. These new drugs have demonstrated efficacy and safety in clinical trials for both episodic and chronic migraine, and results from their real-world experience are being increasingly reported in literature. In this review, we provide an overview of anti-CGRP drugs and their placement in migraine prevention.

24

News (Medical) associated with Eptinezumab-JJMR

11 Mar 2024

·www.prnewswire.com

American Headache Society Publishes Updated Guidance on Migraine Preventive Therapy

Recommends therapies targeting calcitonin gene-related peptide (CGRP) as a first-line option for migraine prevention MOUNT ROYAL, N.J., March 11, 2024 /PRNewswire/ -- The American Headache Society (AHS) published a consensus position statement today in Headache: The Journal of Head and Face Pain about the first-line role CGRP-targeting therapies should play in the prevention of migraine. Specifically, the AHS calls for CGRP-targeting therapies to be considered as a first-line approach for migraine prevention, along with previous first-line treatments, without a requirement for prior failure of other classes of migraine preventive treatment. The goal of preventive treatment is to reduce the frequency, intensity, duration, and disability associated with migraine attacks. AHS, the leading medical and scientific organization for healthcare professionals in migraine and other headache disorders, estimates that preventive therapy is indicated for approximately 40% of people with migraine, and many are unable to use existing first-line preventive migraine medicines due to limited effectiveness and tolerability. After a comprehensive review of clinical trial and real-world experience, the AHS found the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies—such as monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small-molecule CGRP receptor antagonists (rimegepant and atogepant)—for migraine prevention to be substantial in its volume, scope, and quality. "Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," said Andrew Charles, MD, FAHS, position statement co-author and president of the American Headache Society. "Elevating CGRP-targeting therapies to the first line should reduce barriers for patients to receive these effective treatments and bring hope to countless people who experience this invisible, yet debilitating disease." The new position statement from the AHS, "Calcitonin gene-related peptide (CGRP)-targeting therapies are a first-line option for the prevention of migraine," provides guidance on how to integrate these treatments into clinical practice. ABOUT MIGRAINE Migraine is the third most common disease in the world. In the United States, an estimated 40 million Americans live with migraine. While migraine symptoms vary from person to person, common symptoms include severe headache; nausea and/or vomiting; increased sensitivity to light, sound, or smells; depressed mood or changes in mood; and yawning, fatigue, and difficulty sleeping. ABOUT THE AMERICAN HEADACHE SOCIETY The American Headache Society strives to improve the lives of people impacted by migraine and other headache disorders. The AHS is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society's objective is to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals, and the public while encouraging scientific research are the primary functions of our Society. Learn more at AmericanHeadacheSociety.org. This consensus statement published by the American Headache Society (AHS) is an assessment of current scientific and clinical information that is provided as an educational service. The information should not be considered inclusive of all appropriate treatments. New evidence may develop between the time this statement is submitted and when it is published or read. This statement addresses only the question that is specifically identified. It does not mandate any particular course of medical care and is not intended to substitute for the independent professional judgment of the treating provider. CONTACT Tanya Kiniry [email protected] SOURCE American Headache Society

23 Jan 2024

·www.fiercepharma.com

Lundbeck CEO eyes deals to bolster pipeline, complement growth drivers ahead of patent losses

Charl Van Zyl took the helm at Lundbeck in October after several years at UCB. Lundbeck’s Charl van Zyl has about 100 days under his belt as the company’s new CEO. For the next 100 days and beyond, the chief exec is buckling down on his efforts to sustain the company's growth trajectory through upcoming patent cliffs. Van Zyl came to Lundbeck after a six-year stint at UCB, where he most recently served as that company’s head of neurology solutions. UCB credited the exec with integrating two major acquisitions after UCB bought Zogenix for $1.9 billion in 2022 and Ra Pharma for $2.5 billion in 2019. With that experience, van Zyl could be ready to strike deals for his new employer. Under a goal to bolster long-term growth prospects, Lundbeck’s approach to M&A is really “programmatic" and "systemic,” the CEO said in a recent interview. The strategy could include a series of “two or three” deals that build on the company’s existing strengths and enable it to balance its pipeline, the chief said. For now, Lundbeck has two strong growth drivers on hand with its antipsychotic Rexulti, which recently scored an FDA approval for Alzheimer’s disease agitation, and the migraine med Vyepti. Lundbeck's commercial efforts on those meds will command much of the company's attention as it works to grow in the medium term, the CEO said. Recently, Rexulti overtook the antidepressant Trintellix/Brintellix as Lundbeck’s top brand by sales, bringing in a haul of 3.3 billion DKK ($481 million) over the first nine months of 2023. The drug is still early in its Alzheimer’s agitation launch, but with a high unmet need in an area with “huge societal impact,” van Zyl is confident that for Lundbeck, “this is the right space to be [in].” The drug's rise comes at a good time. The company’s long-time largest product, Trintellix/Brintellix, is slated to lose patent protection at the end of 2026. Rexulti loses exclusivity in 2029, allowing Lundbeck a longer runway to grow the brand. Currently, Lundbeck is “investing significantly” to grow the med in its new use, particularly in the U.S. with direct-to-consumer ads, the CEO said. With a “strong cash flow” and a solid financial position, the time is right to invest and grow, van Zyl emphasized. Lundbeck's former CEO, Deborah Dunsire, stepped down in June after the 109-year-old company hit a record high for quarterly revenues. In a broader sense, the primary focus across the industry going into 2024 is trending toward setting the bar “very high” for innovation, especially in areas of unmet need. As for Lundbeck, the drugmaker is specifically active in chronic neuroscience as it looks to address lifelong conditions. Like many of its peers, upcoming patent cliffs are pushing Lundbeck toward building a pipeline that can deliver over many years. The company’s pipeline is still in relatively early stages, with many assets in phase 1 and phase 2. But out of those, van Zyl is “really excited” about its migraine prospects. In April, the drugmaker read out positive results of a proof-of-concept study testing a new migraine approach. If successful, the asset could complement Vyepti and help Lundbeck build out a portfolio of migraine prevention medicines.

AcquisitionExecutive ChangeDrug ApprovalPhase 2

19 Jan 2024

·endpts.com

Lundbeck encourages migraine patients to ‘Say Yep’ to its IV-infused med in latest campaign

Lundbeck is taking a new tack in its migraine marketing for Vyepti, the only IV-infused option in the crowded market. The campaign, launched this week, reinforces the brand name with a “Say Yep” reminder and not having to worry about daily migraine management. The TV ad uses over-the-top characters — an annoying co-worker, a school PTA leader, and a restaurant server — to loudly point out daily struggles to a young woman making her way through her day. The co-worker, for instance, flashes a giant cheesy grin and plunks a huge folder on her desk, saying “Who’s excited to work around the clock and do way too much managing migraine?”

100 Deals associated with Eptinezumab-JJMR

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Eptinezumab-JJMR	L01XC	DB14040

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	Lundbeck Seattle BioPharmaceuticals, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Headache Disorders, Secondary	Phase 3	CN	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	GE	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	KR	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	ES	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	TW	H. Lundbeck A/S	17 Feb 2021
Cluster Headache	Phase 3	US	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	JP	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	BE	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	CZ	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	DK	H. Lundbeck A/S	23 Dec 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05284019 (CTgov)	Phase 4	Migraine Disorders	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	xwfjutyhlg(ueaijqwwhn) = suqdczfhfz raqhnjjwob (yatbbfpeev, lmwedofpal - fuwbzjdaec) View more	-	29 May 2024
				Eptinezumab (Eptinezumab)	xwfjutyhlg(ueaijqwwhn) = lmayjdheuy raqhnjjwob (yatbbfpeev, jocnohtysj - ywyhefplve) View more
NCT04418765 (DELIVER, AAN2023)	Phase 3	Migraine Disorders	890	Eptinezumab 100mg	efjldxjium(yomisdncqm) = rpoywtbrqa dgmpoqruex (sehvxowwzr )	-	25 Apr 2023
				Eptinezumab 300mg	efjldxjium(yomisdncqm) = ayaaeapizi dgmpoqruex (sehvxowwzr )
AAN2023	Not Applicable	-	31	Eptinezumab 100mg	xqohlyfooc(giasbpezjn) = 77.4% reported that treatment improved disability/function after 6 months of use xikgixlbrw (ysbgpxoomu ) View more	Positive	25 Apr 2023
NCT02974153 (PROMISE-2, AAN2023)	Phase 3	Migraine Disorders \| Headache Disorders, Secondary	1,072	Eptinezumab 100mg	kxkfdgfvkk(fqevklkzft) = qimhcgwjam yvanzuzqsv (qrgysznluh ) View more	Positive	25 Apr 2023
				Eptinezumab 300mg	kxkfdgfvkk(fqevklkzft) = gzildpoyey yvanzuzqsv (qrgysznluh ) View more
NCT02974153 \| NCT02559895 (PROMISE studies, Pubmed)	Not Applicable	Migraine Disorders	-	Eptinezumab 100 mg	fjvaasptsj(fftfgkodln) = scruhqedmt owiiiuxtnn (yszxstjtwa )	-	25 Oct 2022
				Eptinezumab 300 mg	fjvaasptsj(fftfgkodln) = eqoerkewgr owiiiuxtnn (yszxstjtwa )
ANA2022	Not Applicable	Migraine Disorders	-	Eptinezumab 100mg	ifqzsmnuyg(kykxcjnaul) = blnmpftnll rvesrivjqq (mcyfdgwssj )	-	14 Sep 2022
				Eptinezumab 300mg	ifqzsmnuyg(kykxcjnaul) = wrpuijrjqg rvesrivjqq (mcyfdgwssj )
NCT02974153 (PROMISE-2, Pubmed)	Phase 3	Migraine Disorders	1,072	Eptinezumab 100mg	vdpqvwwenn(sztqberrvf) = abwdzjgoil lghalgsghi (crpiifddwt )	Positive	06 Sep 2022
				Eptinezumab 300mg	dbaqddyzol(wpmxvwrpjt) = xiepnutzdu ubmvsfkrct (rtvaffvotf ) View more
NCT04152083 (RELIEF, Pubmed)	Phase 3	Migraine Disorders	485	Eptinezumab 100 mg	cdtfkvivnw(wxpzhiwgbl) = qaetukbhcr aagcgffvvj (krurzvkzea )	Positive	28 Jul 2022
				Placebo	cdtfkvivnw(wxpzhiwgbl) = pzkpxtzgwd aagcgffvvj (krurzvkzea )
NCT02985398 (PREVAIL, Pubmed)	Phase 3	Migraine Disorders	128	Eptinezumab	xkqsledkdw(hfazdxfuuh) = dvgnynwunb amzdmadkbv (hqlngpnram ) View more	-	08 Jul 2022
NCT04152083 (RELIEF, Pubmed) Manual	Phase 3	Migraine Disorders	480	eptinezumab	sxjmkwhonz(lgahworcay) = aoauktepgo wtbfsupmgu (ekrjqqtijf ) View more	Positive	03 Jun 2022
				Placebo	sxjmkwhonz(lgahworcay) = wzmibcqobg wtbfsupmgu (ekrjqqtijf ) View more