Novartis Announces Positive Phase IV Head-to-Head Study: Aimovig Demonstrates Superior Tolerability and Efficacy Over Topiramate in Migraine Prevention

November 03, 2020 /Bio ValleyBIOON/ --NovartisNovartis recently announced that the HERMES study (NCT03828539), the first Phase IV, randomized, double-blind, double-dummy, head-to-head trial evaluating the migraine medication Aimovig (erenumab), met its primary and secondary endpoints.

This study was conducted in 777 adult patients with episodic migraine (EM) or chronic migraine (CM) who had not previously received, were unsuitable for, or had failed up to three preventive migraine therapies, and who experienced ≥4 migraine days per month (MMD). The study compared Aimovig (70 mg and 140 mg) with topiramate at the highest tolerated dose (50–100 mg/day). Topiramate is an anticonvulsant commonly used as a standard-of-care therapy for migraine prevention.

The results showed that Aimovig had better tolerability and efficacy than topiramate in preventing migraines. Specifically: (1) Aimovig demonstrated superior tolerability compared to topiramate, with fewer discontinuations during the 24-week treatment period. (2) Aimovig also showed superior efficacy, with a higher proportion of patients achieving at least a 50% reduction in monthly migraine days (MMD). In this study, the safety profile of Aimovig was consistent with previousClinical Trialsconsistent with that in China.

Other findings and detailed results of the primary and secondary endpoints of the HERMES study will be presented at the upcoming medicalMeetingpublished above. Professor Uwe Reuter, Medical Director at Charité University Hospital, stated, “Data from this first-in-class head-to-head study further confirm the value of Aimovig as a safe and effective preventive treatment for migraine. These findings also provide new insights into migraine management for physicians and patients.”

Estelle Vester Blokland, Global Head of Neuroscience Medical Affairs at Novartis, stated: “Aimovig remains the anti-CGRP therapy with the most extensive experience in safety and efficacy, and these results further underscore that Aimovig can significantly alleviate migraine compared with oral medications.”Novartis“Remains firmly committed to reimagining migraine care globally, contributing to improving the lives of patients suffering from this highly debilitating neurological disorder.”

Aimovig is the first globally approved migraine medication targeting the calcitonin gene-related peptide (CGRP) pathway., the drug is co-commercialized by Novartis and Amgen in the United States. Amgen holds exclusive commercialization rights in the Japanese market,NovartisPossesses exclusive commercialization rights in the rest of the world.

Aimovig is the most prescribed anti-CGRP therapy worldwide. Since its launch, over 480,000 patients across 44 countries globally have been prescribed Aimovig. Furthermore, Aimovig is the only therapy with up to 5 years of data in both episodic and chronic migraineClinical TrialData on CGRP-R inhibitors, which broadens the data scope and demonstrates the long-term safety and efficacy of treatment for migraine patients.

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 hot targets for the development of migraine medications.

To date, four monoclonal antibody therapies for migraine targeting CGRP and its receptor have been launched, namely: Amgen/NovartisAimovig, Teva's Ajovy,Eli LillyEmgality, Lundbeck’s Vyepti (eptinezumab). Regarding administration, Aimovig and Emgality are both administered via subcutaneous injection once monthly; Ajovy is administered via subcutaneous injection either once monthly or once every three months; Vyepti is administered via intravenous infusion once every three months.

In addition, some pharmaceutical companies are developing oral CGRP receptor antagonists. Currently marketed products include Allergan’s Ubrelvy (ubrogepant) and Biohaven’s Zydis ODT (rimegepant orally disintegrating tablets), both indicated for the acute treatment of migraine (with or without aura) in adults. Notably, in October 2019,Eli LillyOral Drug Reyvow (lasmiditan) Approved in the United StatesFDAApproved for the acute treatment of migraine (with or without aura) in adults. This drug is a 5-HT1F agonist and represents the first new class of acute migraine therapies approved in two decades. (Bioon.com)

Original Source: Novartis announces positive results from a Phase IV study showing superior tolerability and efficacy of Aimovig® (erenumab) compared with topiramate in migraine prevention