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

  • The first randomized, double blind, head-to-head study of Aimovig (erenumab) against topiramate in patients with episodic and chronic migraine (HER-MES) achieved superiority in its primary and secondary endpoints
  • Aimovig showed superior tolerability and efficacy against topiramate and provided a significant reduction in monthly migraine days (MMDs)
  • Aimovig is the most prescribed anti-calcitonin gene-related peptide pathway (anti-CGRP) therapy worldwide, with more than 480,000 patients prescribed across 44 countries since launch1

Basel, November 2, 2020 - Novartis announced today that HER-MES, the first Phase IV, randomized, double-blind, double-dummy, head-to-head study of Aimovig (erenumab) against topiramate, an anticonvulsant, in patients with episodic and chronic migraine met its primary and secondary endpoints. The results of HER-MES showed that Aimovig had a superior tolerability and efficacy profile than topiramate, with less discontinuation over the course of the 24-week treatment phase. Aimovig also showed superior efficacy, with a greater proportion of patients achieving a 50% reduction in their monthly migraine days (MMDs).

"The data generated by this first of a kind head-to-head study reinforces the value of erenumab as a safe and effective migraine prevention treatment. The findings also provide novel insights into migraine therapy for physicians and patients," said Prof. Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin.

"With Aimovig continuing to be the anti-CGRP treatment with the longest safety and efficacy experience, these results further emphasize its potential to provide significant relief from migraine with an infrequent dosing compared with the oral treatment," said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. "Novartis remains fiercely committed to reimagining migraine care worldwide, contributing to the improvement of life for people living with this highly debilitating neurological disease."

HER-MES aimed to determine the tolerability and efficacy of Aimovig 70 mg and 140 mg compared with topiramate, an anticonvulsant commonly used as standard of care in migraine prevention, in the highest tolerated dose (50-100 mg daily). The study enrolled 777 adult patients suffering from