Erenumab (Genetical Recombination)

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.

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