Novartis has announced that first Phase IV HER-MES study of Aimovig (erenumab) against topiramate in patients with episodic and chronic migraine met its primary and secondary endpoints.
Aimovig is designed to target the calcitonin gene-related peptide (CGRP) receptor associated with migraine. It is jointly marketed by Amgen and Novartis in the US.
The two-armed, randomised, double-blind, double-dummy, head-to-head, parallel group study analysed the tolerability and efficacy of Aimovig 70mg and 140mg versus topiramate, an anticonvulsant, in a patient-centred setting.
It enrolled 777 adult patients with episodic or chronic migraine who were naïve to, not suitable for, or had previously failed up to three prophylactic migraine treatments with propranolol/metoprolol, amitriptyline and flunarizine.
The results of the study showed that Aimovig demonstrated superior tolerability and efficacy profile than topiramate. The therapy showed less discontinuation over the course of the 24-week treatment phase, meeting the trial’s primary endpoint.
Aimovig also showed superior efficacy, with a greater proportion of patients achieving at least 50% reduction in their monthly migraine days (MMDs), meeting the secondary endpoint.
Novartis Pharmaceuticals Neuroscience Medical Affairs global head Estelle Vester-Blokland said: “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.”
Fully developed in Germany, the HER-MES study was conducted across 82 centres from February end last year to July end this year.
Aimovig’s safety profile in the study was consistent with those seen in previous ones.
Last month, Amgen reported positive long-term data from a Phase II trial of Aimovig in patients with episodic migraine.