Two extension studies confirm efficacy and safety of Aimovig in migraine.- Novartis.

Novartis announced the results of two open-label extension studies (OLE) of Aimovig (erenumab) in patients with chronic and episodic migraine, which reinforce the established safety and efficacy profile of Aimovig in long-term use for patients with chronic migraine. In addition, data were presented from the longest running study of a CGRP therapy, demonstrating the long-term safety and tolerability of Aimovig in episodic migraine.

Aimovig is 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.In the study in chronic migraine patients (15 or more migraine days per month), the primary and secondary endpoints were long-term safety and efficacy, respectively. The safety results after one year were consistent with the established safety profile of Aimovig in previous studies. The most frequent adverse events (AEs) were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia, and migraine.The efficacy data showed sustained benefits up to one year. Compared to a baseline of 18.1 average monthly migraine days, patients taking Aimovig 140mg and 70mg (based on last dose received) respectively achieved a substantial reduction of average monthly migraine days - 10.5 and 8.5 days 50% or more reduction in monthly migraine days - 67% and 53% 75% or more reduction in monthly migraine days - 42% and 27% Migraine-free status (100% reduction) - 13% and 6%.

The results from a three-year interim data analysis of the five-year OLE study assessing safety in episodic migraine (four or more migraine days per month) showed Aimovig had a safety profile consistent with the spectrum and rate of AEs seen in shorter-term placebo-controlled studies. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza, and back pain and there were no new safety signals. The data were presented at the 60th Annual Scientific Meeting of the American Headache Society in San Francisco.

Comment: Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. Aimovig is the only CGRP inhibitor that does not need a loading dose or intravenous administration.