Novartis/Amgen migraine drug reduces attacks after others fail

Novartis and Amgen’s Aimovig migraine drug has met its goal of reducing attacks in a trial of patients who have tried multiple therapies without success.

Results of the LIBERTY trial come as regulators on both sides of the Atlantic review Aimovig (erenumab) in migraine.

A group of companies are bidding to get the first calcitonin gene-related peptide (CGRP) inhibitor class drug to market, and Novartis and Amgen are currently in front, with an FDA decision due before mid-May.

Building on some already convincing late-stage results that form the basis of the European and US filings, the phase 3b LIBERTY trial assessed efficacy and safety of Aimovig in patients with episodic migraine who had failed to respond to four previous treatments, or found their side-effects intolerable.

The study met its primary efficacy endpoint, with significantly more patients taking Aimovig experiencing at least a 50% reduction from baseline in their monthly migraine days compared with placebo.

Liberty also met all its secondary endpoints including reduction of monthly migraine days, reduction in days needing acute rescue medication, and number of patients with no monthly migraine days.

On the safety side, the companies said Aimovig has a “placebo-like” safety profile.

With Aimovig, Novartis and Amgen are competing against four other CGRP drugs that are also closing in on the market and the data from LIBERTY could help give an edge over these rivals should they get to market.

Eli Lilly last month filed its CGRP drug galcanezumab in the US, while Teva has also filed its fremanezumab with the FDA. Also in the hunt is Alder BioPharmaceuticals and its eptinezumab.

Teva’s drug is most fancied by analysts, with the pharma chasing approval in both chronic and episodic migraine indications.

Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis, said: “The results add to the consistent body of evidence for erenumab across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years. We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible.”

Under a deal struck in 2015 and expanded last year, the companies will co-market Aimovig in the US and Japan, while Novartis has marketing rights in Europe, Canada and the rest of the world.

The companies are also developing a phase 3 beta-secretase 1 inhibitor for Alzheimer’s disease under the same agreement.

 

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