Novartis and Amgen’s Aimovig Demonstrates Superior Tolerability and Efficacy Over Topiramate in Phase 4 Head-to-Head Migraine Prevention Trial

November 11, 2021 /BioValleyBIOON/ --NovartisNovartis and Amgen recently jointly announced that the data from the first Phase IV, randomized, double-blind, double-dummy, head-to-head study HER-MES (NCT03828539) evaluating the migraine drug Aimovig (erenumab) has been published in the medical journal Cephalalgia.

The HER-MES study was conducted in 777 adult patients with episodic migraine (EM) or chronic migraine (CM) who had either not received prior treatment, were unsuitable for, or had failed up to three preventive migraine therapies. These patients experienced a monthly migraine days (MMD) count of ≥4 days. The study compared Aimovig (70mg and 140mg) with the highest tolerated dose (50-100mg/day) of topiramate.Topiramate is an anticonvulsant drug commonly used as a standard care therapy for migraine prevention, with up to 600,000 new prescription patients annually in the United States.

The results showed,Compared with Topiramate, Aimovig has higher tolerability and efficacy in the prevention of migraine.Specifically: (1) Aimovig is better tolerated than topiramate,The discontinuation rate due to adverse events during the 24-week treatment period was significantly reduced (10.6% vs 38.9%)..(2) Aimovig also demonstrated superior efficacy,A higher proportion of patients experienced at least a 50% reduction in monthly migraine days (MMD) (55.4% vs 31.2%).。Positive results in the Aimovig group translate into significant improvements in patients' quality of life and functional impairment.In the study, the safety of Aimovig was consistent with that seen in prior clinical studies.

Charité University Medicine's Medical Director, Professor Uwe Reuter, stated: "HER-MES is the first study to directly compare the therapeutic effects of antibodies and small molecules in migraine prevention."The positive results reinforce Aimovig's position as a safe and effective preventive therapy for migraine, significantly improving the quality of life for patients with an improved dosing regimen."

NovartisLykke Hinsch Gylvin, Global Medical Franchise Head of Neuroscience at Novartis, stated: "The results from this first and only head-to-head study show that Aimovig has better tolerability and efficacy compared to topiramate, further demonstrating the value of Aimovig for migraine patients. We are proud to continue reimagining migraine care by providing safe and effective preventive treatment options for people living with migraines."

Aimovig is the world's first approved migraine drug targeting the calcitonin gene-related peptide (CGRP) receptor, co-commercialized by Novartis and Amgen in the United States. Amgen holds exclusive commercialization rights in the Japanese market.NovartisHolding exclusive commercialization rights in the rest of the world. Aimovig is the most prescribed anti-CGRP therapy worldwide, with more than 520,000 patients globally having been prescribed Aimovig for treatment since its launch.

Calcitonin Gene-Related Peptide (CGRP) is a neuropeptide that has been shown to be released during migraine attacks and is considered a trigger for migraine episodes. Currently, CGRP and its receptor have become popular targets for migraine drug development.

As of now, four monoclonal antibody therapies targeting CGRP and its receptor for migraine have been launched, respectively: Amgen/NovartisAimovig, Teva Ajovy,Eli LillyEmgality, Lundbeck's Vyepti (eptinezumab). In terms of administration, both Aimovig and Emgality are administered once a month via subcutaneous injection, Ajovy can be administered once a month or once every 3 months via subcutaneous injection, and Vyepti is administered once every 3 months via intravenous infusion.

Some other pharmaceutical companies are developing oral CGRP receptor antagonists. Currently on the market is AbbVie'sUbrelvy（ubrogepant）and Biohaven CompanyZydis ODT (Rimegepant Orally Disintegrating Tablets), Two drugs for the acute treatment of adult migraine (with or without aura). At the end of September this year, AbbVieQulipta（atogepant）Obtained in the United StatesFDAApproved, becoming the first oral CGRP receptor antagonist for the preventive treatment of migraine. (Bioon.com)

Source of Original Text:Novartis announces new publication in Cephalalgia of data showcasing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention