Delving into the Latest Updates on Erenumab (Genetical Recombination) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

erenumab, Erenumab (Genetical Recombination), erenumab (r-INN)

+ [5]

Target

CGRP receptor

Mechanism

CALCRL antagonists(Calcitonin gene-related peptide type 1 receptor antagonists)

Therapeutic Areas

Nervous System DiseasesMouth and Tooth DiseasesSkin and Musculoskeletal Diseases

Active Indication

Migraine DisordersTemporomandibular Joint Disorders

Inactive Indication

Angina, StableFlushingHeadache+ [8]

Originator Organization

Amgen, Inc.

Active Organization

Novartis Pharmaceuticals Corp.Amgen KK

Amgen, Inc.

+ [5]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (17 May 2018),

Migraine Disorders

Regulation-

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Gene Sequence

Sequence Code 10103843L

Source: *****

Sequence Code 10265161H

Source: *****

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).
This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:
Investigational Drug Sub-Study A: Siltuximab
Investigation Drug Sub-Study B: Erenumab-Aooe

Start Date31 Aug 2023

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

[+2]

NCT05281770 / RecruitingNot ApplicableIIT

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

Start Date01 Oct 2022

Sponsor / Collaborator

Medical University of Vienna

[+1]

NCT05142228 / TerminatedPhase 2IIT

Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP)

This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo.
A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

Start Date31 May 2022

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

100 Clinical Results associated with Erenumab (Genetical Recombination)

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100 Translational Medicine associated with Erenumab (Genetical Recombination)

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100 Patents (Medical) associated with Erenumab (Genetical Recombination)

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496

Literatures (Medical) associated with Erenumab (Genetical Recombination)

01 Feb 2025·Neurology-Clinical Practice

Efficacy and Tolerability of Anti-CGRP Monoclonal Antibodies in Patients Aged ≥ 65 Years With Daily or Nondaily Migraine

Article

Author: Ahmed, Zubair ; Hennessy, Elise ; Mays, Maryann ; Sonneborn, Claire ; Suneja, Aarushi ; Hogue, Olivia ; Salim, Amira ; Biswas, Sudipa ; Mata, Ignacio F.

Background and Objectives:

Despite decreasing prevalence of migraine with advancing age, there remains a significant proportion of individuals aged ≥65 years with migraine. Treatment of this population is difficult and they are often excluded from clinical trials, limiting evidence regarding migraine treatment outcomes. Our objective is to assess the efficacy and tolerability of anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) therapies (erenumab, fremanezumab, and galcanezumab) in patients ≥65 years (O65) compared with patients <65 (U65) with daily or nondaily migraine.

Methods:

This observational study uses retrospective data from the electronic medical records of patients who were treated with an anti-CGRP mAb between June 2018 and November 2021. Efficacy was determined through a reduction in monthly migraine days (MMDs) and Headache Impact Test (HIT-6) scores from baseline to posttreatment. Tolerability was examined through the number of adverse events reported per group. Mann-Whitney tests were used to compare the efficacy and tolerability of U65 and O65 patients overall and separated into daily and nondaily migraine groups.

Results:

The dataset consisted of U65 (n = 2,707; median [interquartile range]; 45.4 [35.8-53.8] years) or O65 (n = 304; 69.5 [67.3-73.3] years) and further separated into daily (n = 1,303) and nondaily (n = 1,708) migraine. There was no difference (p = 0.57) in the median MMD reduction between U65 (10 days [0.0-17.0]) and O65 (10 days [0.0-16.5]). Similarly, no difference was found among patients with nondaily migraine (p = 0.82) and patients with daily migraine (p = 0.59). HIT-6 scores decreased from severe to moderate/substantial impact for all groups. The daily and nondaily groups showed differences in meeting the 50% improvement threshold (nondaily U65, 67% vs daily U65, 54%, p < 0.0001; nondaily O65, 65% vs daily O65, 49%, p = 0.008). Side effects were reported (829/3,011), with a higher incidence in the U65 (22% O65, 28% U65). The most common side effects for both groups were injection site reaction/rash (40%) and constipation (25%).

Discussion:

This retrospective analysis provides real-world evidence that there is no difference in the efficacy and tolerability of treatment with erenumab, fremanezumab, and galcanezumab in patients O65 when compared with patients U65 both with daily or nondaily migraine. These data may help guide the choice of migraine treatment in older populations.

01 Dec 2024·Pain and Therapy

Real-World Experience of Erenumab in Patients with Migraine in Germany: The SPECTRE Study

Article

Author: Göbel, Hartmut ; Baufeld, Caroline ; Weiss, Cordula ; Holle, Dagny ; Koch, Mirja ; Gendolla, Astrid ; Gaul, Charly

INTRODUCTION:

To provide real-world insights into migraine patient population in Germany treated with erenumab, focusing on the prescription patterns and reasons for the initial dosage choice.

METHODS:

SPECTRE was an observational, non-interventional, multicenter, open-label, single-arm study in patients treated with erenumab according to approved local dose and guidelines. The study enrolled adult patients (n = 571; Germany: 105 sites) with migraine who had received erenumab for not more than 3 months before the start of the study.

RESULTS:

The mean (standard deviation) patient age was 45.0 (12.3) years, and most patients were female (89.0%), Caucasian (97.6%), and non-smokers (85.1%). The starting dose of erenumab was 70 mg in 68.5% of patients and 140 mg in 31.5%. The proportion of patients with 140 mg as the starting dose was the highest (43.5%) in those aged 30-40 years. The most common reason for starting a higher dose of erenumab 140 mg was severity of migraine (47.4%). During the observational period, the proportion of patients taking erenumab 140 mg increased to 64.6% (visit 5; V5) after 12 months. Due to attrition of patients towards the end of the study (V9: 90 participants), data at V9 must be interpreted with caution. At least one dose change was performed in 45.3% of patients (i.e., erenumab 70 to 140 mg or 140 to 70 mg), 21.2% of patients attempted at least once to discontinue treatment (i.e., period with erenumab discontinuation and no other antibody treatment for migraine prevention), and 15.3% discontinued erenumab treatment, mainly because of no or insufficient treatment response (13.5%). The mean time until the first omission attempt was 332.3 (range 37-633) days. Constipation (12.1%) was the most frequently reported adverse event, in line with the summary of product characteristics (SmPC) of erenumab.

CONCLUSION:

Most patients with migraine were prescribed erenumab 70 mg as the starting dose. No new safety signals were observed for erenumab versus the previous trials.

01 Dec 2024·EUROPEAN JOURNAL OF NEUROLOGY

Erenumab versus topiramate: migraine‐related disability, impact and health‐related quality of life

Article

Author: Reuter, Uwe ; Hentschke, Christian ; Gendolla, Astrid ; Heinze, Axel ; Sieder, Christian

Abstract:

Background and purpose:

HER‐MES was the first head‐to‐head study of erenumab against topiramate (standard of care). This post hoc analysis of the HER‐MES study evaluated the effect of erenumab versus topiramate on patient‐reported outcomes at week 24.

Methods:

Adult patients with episodic or chronic migraine (n = 777) were randomized (1:1) to monthly subcutaneous erenumab (n = 389) or daily oral topiramate (n = 388). Migraine‐related disability, as measured by the Headache Impact Test 6 (HIT‐6) and Short Form 36 Health Survey version 2 (SF‐36v2), was analysed in the entire study cohort and true completers.

Results:

In the erenumab group (vs. topiramate), significant improvements were reported in Headache Impact Test 6 total scores (composite populations, −10.88 vs. −7.72; true completers, −11.92 vs. −10.61) and a higher proportion of patients achieved a ≥5‐point reduction from baseline with erenumab (composite populations, 72.2% vs. 53.9%; true completers, 79.64% vs. 71.43%). The adjusted mean change from baseline in the SF‐36v2 score was greater with erenumab for both physical component summary (composite population, 5.48 vs. 3.63; true completers, 5.95 vs. 5.23) and mental component summary (composite populations, 1.00 vs. −1.18; true completers, 1.74 vs. −0.33). A higher proportion of patients on erenumab versus topiramate had a ≥5‐point improvement in SF‐36v2 for the physical component summary (composite populations, 47.7% vs. 37.4%; true completers, 52.1% vs. 48.9%) and mental component summary (composite populations, 25.3% vs. 16.8%; true completers, 27.3% vs. 17.7%).

Conclusions:

This post hoc analysis demonstrated that patients treated with erenumab had significant improvements in headache impact and quality of life as measured by patient‐reported outcomes versus patients treated with topiramate.

32

News (Medical) associated with Erenumab (Genetical Recombination)

18 Sep 2024

·www.drugs.com

Erenumab Effective for Nonopioid Medication Overuse Headache in Chronic Migraine

WEDNESDAY, Sept. 18, 2024 -- Monthly use of erenumab injections (140 mg) is safe and effective in achieving medication overuse headache (MOH) remission in patients with nonopioid chronic migraine (CM) and MOH, according to a study published online Sept. 16 in JAMA Neurology . Stewart J. Tepper, M.D., from the New England Institute for Neurology and Headache in Stamford, Connecticut, and colleagues assessed the safety and efficacy of erenumab in patients with nonopioid CM-MOH. The analysis included 584 participants randomly assigned to erenumab (70 mg or 140 mg) or placebo, once monthly for 24 weeks. The researchers found that at month 6, 69.1 percent of participants in the erenumab 140-mg group (odds ratio, 2.01; 95 percent confidence interval, 1.33 to 3.05; P < 0.001 versus placebo) and 60.3 percent in the erenumab 70-mg group (odds ratio, 1.37; 95 percent confidence interval, 0.92 to 2.05; P = 0.13 versus placebo) achieved MOH remission versus 52.6 percent of participants in the placebo group. From baseline, least squares mean change in average monthly acute headache medication days was –9.4 days in the erenumab 140-mg group (difference from placebo, –2.7) and –7.8 days in the erenumab 70-mg group (difference from placebo, –1.2). Throughout the treatment period, MOH remission was sustained in 61.3 percent of participants in the erenumab 140-mg group, 49.5 percent of participants in the 70-mg group, and 37.6 percent in the placebo group. The safety profile was similar to that seen in previous trials, with treatment-emergent adverse event incidence in the combined erenumab group of 66.8 percent, including most commonly constipation (15.2 percent) and COVID-19 (13.9 percent). "This study is the first controlled trial to provide American Academy of Neurology class I evidence of beneficial effects of a migraine preventive treatment in patients with CM-MOH (nonopioid)," the authors write. Several authors disclosed ties to pharmaceutical companies, including Amgen, which manufactures erenumab and funded the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

18 Jul 2024

·firstwordpharma.com

Teva touts first CGRP success in Phase III paediatric migraine prevention study

Teva is looking to expand its migraine prevention portfolio into the paediatric market, announcing positive results Thursday from the Phase III SPACE study evaluating Ajovy (fremanezumab) in children and adolescents. According to Teva, this is the first time an anti-CGRP monoclonal antibody has shown efficacy in this population.Teva estimates that migraines affect about 7.7% of children, with prevalence rising from 5% in kids aged 5 to 10 to around 15% in teenagers. "The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them," said Chief Medical Officer Eric Hughes.The trial randomised 235 subjects between the ages of 6 and 17 years to receive subcutaneously administered Ajovy or placebo over a 12-week period to prevent episodic migraines. Teva said the study met its primary endpoint, with Ajovy patients experiencing significantly fewer monthly migraine days compared to placebo."The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations," the company said.So far, all other CGRP antibodies in the US — Amgen's Aimovig (erenumab), Lundbeck's Vyepti (eptinezumab) and Eli Lilly's Emgality (galcanezumab) — are only approved for adults. Ajovy was greenlit in the US as a preventative migraine treatment for adults in 2018 and was later also cleared in Europe.Amgen and Lundbeck are also testing their respective products in paediatric patients with chronic or episodic migraine. Aimovig is being evaluated in Amgen's OASIS(EM) and OASIS(CM) studies, both due to complete in 2027, while Vyepti is being investigated in the Phase III PROSPECT-1 and PROSPECT-2 trials, which are expected to wrap up towards the end of this year.Teva noted that the efficacy seen in the SPACE study was "consistent" with pivotal Phase III and real-world evidence in adults. No new emergent safety signals emerged. Full data will be presented at a medical meeting later this year.

Phase 3Clinical ResultDrug Approval

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

100 Deals associated with Erenumab (Genetical Recombination)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Erenumab (Genetical Recombination)	N02CD01	DB14039

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	Amgen, Inc.	17 May 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuralgia	Phase 2	US	Amgen, Inc.	31 May 2022
Trigeminal Nerve Diseases	Phase 2	US	Amgen, Inc.	31 May 2022
Temporomandibular Joint Disorders	Phase 2	US	Novartis Pharmaceuticals Corp.	15 Nov 2021
Temporomandibular Joint Dysfunction Syndrome	Phase 2	US	-	21 Oct 2021
Flushing	Phase 2	DK	Novartis Pharmaceuticals Corp.	09 Jun 2020
Rosacea	Phase 2	DK	Novartis Pharmaceuticals Corp.	09 Jun 2020
Headache	Phase 2	DK	Novartis AG	05 Apr 2019
Headache	Phase 2	DK	Amgen, Inc.	05 Apr 2019
Post-Concussion Syndrome	Phase 2	DK	Amgen, Inc.	05 Apr 2019
Post-Concussion Syndrome	Phase 2	DK	Novartis AG	05 Apr 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04084314 (APOLLON, Pubmed \| J Headache Pain) Manual	Phase 4	Migraine Disorders	701	Erenumab	sernlwtbke(lukpikoasn) = 4.1% of total cohort discontinued erenumab treatment during open-label treatment phase. Out of these, 65.5% (N = 19) were considered treatment-related. jgaetszzsp (ssygiwnpom )	Positive	25 Sep 2024
				Erenumab (females)
NCT04825678 (CTgov)	Phase 4	Migraine Disorders	240	Erenumab (Erenumab QM: Continued SoC)	fmxhdojzjf(uthptswiuq) = wynexvdghk zkifidfrau (ekraukhxwl, iypjincvwm - hwpjsadmbg) View more	-	19 Sep 2024
				Erenumab (Erenumab QM: Discontinued SoC)	fmxhdojzjf(uthptswiuq) = doufxqkdry zkifidfrau (ekraukhxwl, nwsiwabqir - riumsubcvt) View more
NCT03971071 (Pubmed \| JAMA Neurol) Manual	Phase 4	Migraine Disorders	620	Erenumab 70 mg	oxdtaswrrt(cdkxrnzqca) = jixzkbwduf xcheuvbvlx (djlkiqxgrn ) View more	Positive	16 Sep 2024
				Erenumab 140 mg	oxdtaswrrt(cdkxrnzqca) = eusemgnwaz xcheuvbvlx (djlkiqxgrn ) View more
NCT04252742 (CTgov)	Phase 4	Migraine Disorders	512	Placebo	bmqdacyzje(nkrgpgrekg) = jnvmhwnjjo kulmwsnbft (tmjjftmrmj, nyjdzpxdzo - yimmxdzutl) View more	-	30 Aug 2024
NCT04265755 (INTERROGATE, CTgov)	Phase 4	Migraine Disorders	1,406	Erenumab (Erenumab 70 mg/140 mg)	trgtuwguqf(icswlqeejp) = gqmosctfzl voexuxaceo (fqqshhhduh, kzwfrwvtof - rrfsdhbyzg)	-	07 Jun 2024
				Erenumab (Erenumab 70 mg)	mbomsalgjd(npwwvpbvnh) = gibadcptur gmyfdzezxn (pdjhjechso, oklpxglvxa - vgpsakhrzp) View more
NCT05284019 (EVEC, CTgov)	Phase 4	Migraine Disorders	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	yjpclkgyej(vqgudwverj) = oqocaykfap cedslozuon (ybewzzssin, cjdfrauapc - rbpvryckte) View more	-	29 May 2024
				Eptinezumab (Eptinezumab)	yjpclkgyej(vqgudwverj) = salnfalulq cedslozuon (ybewzzssin, mpndcjjifw - cgfsxckdkj) View more
NCT03096834 (LIBERTY, Pubmed) Manual	Phase 3	Migraine Disorders Third line	151	Erenumab 140 mg	judrovfcov(zcbjbpjago) = The most common treatment-emergent AEs (per 100 person-years) were nasopharyngitis (28.8), influenza (7.5), and back pain (5.8). bcirlvnycx (dlzdeuzeqr )	Positive	01 May 2024
NCT05162027 (TMD CARE, CTgov)	Phase 2	Temporomandibular Joint Disorders	5	Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe (Erenumab-aooe)	jkmvbrtoty(nqkqcmzres) = irraobqdif ovfpuloyvb (hwrjnghyfh, dcjkgycgya - okpwmvugkt) View more	-	02 Apr 2024
				Placebo (Placebo)	jkmvbrtoty(nqkqcmzres) = bhhyzdwzwi ovfpuloyvb (hwrjnghyfh, shobneymru - yxdrhvfevc) View more
NCT05142228 (CTgov)	Phase 2	Trigeminal Nerve Diseases \| Neuralgia	5	Erenumab-Aooe (Erenumab-aooe)	qixmargyhk(umdpnotiuc) = nodmyommao xcnrwhqels (emviarzdjp, vgasqdeeie - mgezkgwrqa) View more	-	22 Mar 2024
				Placebo (Placebo)	qixmargyhk(umdpnotiuc) = ucvyadhtkq xcnrwhqels (emviarzdjp, wrwmopqgum - qtojjqsope) View more
NCT04084314 (APOLLON, CTgov)	Phase 4	Migraine Disorders	701	Erenumab	iznjuvffty(lzemqdqpks) = cdmmnssqsj ffliksovqz (lnzbjqyhyu, kzlqatvitr - oznlyyuwfo) View more	-	06 Feb 2024