Regulatory Affairs

Novartis and Amgen secure FDA approval for migraine drug

PBR Staff Writer Published 18 May 2018

Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.

Aimovig blocks the calcitonin gene-related peptide receptor (CGRP-R), which is considered to play an important role in migraine.

The drug’s effectiveness for the preventive treatment of migraine was assessed in various global, randomized, double-blind, placebo-controlled trials.

The Aimovig clinical program saw participation of over 3,000 patients across four placebo-controlled phase 2 and phase 3 clinical studies and their open-label extensions.

In Phase II and III studies in chronic and episodic migraine, Aimovig was demonstrated to reduce monthly migraine days, including in more difficult-to-treat populations, with majority of patients achieving about a 50% reduction.

The effects on monthly migraine days were shown to be continued for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days a month). 

Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig.

Aimovig 70 mg is self-administered once monthly through Amgen's SureClick autoinjector device, and a loading dose is not required. Novartis and Amgen said some patients could benefit from a dosage of 140 mg once monthly.

Novartis Pharmaceuticals CEO Paul Hudson said: "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine.

“We look forward to working closely with Amgen in the U.S. to bring this treatment to physicians and their patients, who could now gain days of their lives back each month."

Aimovig is expected to be available to patients in the US within one week. The US list price of the drug is $575 for once monthly 70 or 140 mg single-use prefilled SureClick autoinjector(s).

The European Medicines Agency is reviewing the marketing authorization application for Aimovig. The companies expect approval in the European Union in the coming months.


Image: Aimovig blocks the calcitonin gene-related peptide receptor. Photo: courtesy of Novartis.