USFDA approval of Amgen’s Aimovig for preventive treatment of migraine in adults

Amgen has got US Food and Drug Administration (FDA) approval for Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) which is believed to play a critical role in migraine.

Aimovig 70 mg is self-administered once monthly via Amgen’s device, the SureClick autoinjector, and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.

In phase 2 and 3 studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).

A dedicated phase 3b study (LIBERTY) in difficult-to-treat populations those with episodic migraine who have failed two to four prior treatments showed that patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.

The efficacy, tolerability and safety of Aimovig has been assessed in more than 3,000 patients, including LIBERTY and an ongoing open-label extension of up to five years in duration. In clinical studies of Aimovig, the most common adverse reactions were injection site reactions and constipation.

The European Medicines Agency (EMA) Marketing Authorisation Application (MAA) for Aimovig is under review. The companies expect approval in the EU in the coming months.