Episodic migraine: 50% reduction in monthly migraine days with erenumab AMG 334.

Novartis announced positive results from the Phase IIIb LIBERTY study assessing the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects. The study met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo.

LIBERTY also met all secondary endpoints including: reduction of monthly migraine days, reduction in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo.) The safety data are consistent with previous studies of erenumab to date, showing a placebo-like safety profile. Full data will be presented at an upcoming scientific meeting.

Erenumab is the only investigational fully human monoclonal antibody designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. Currently available preventive treatments for migraine have generally been repurposed from other therapeutic areas and are often associated with poor tolerability and lack of efficacy. The safety, efficacy and tolerability of erenumab have been assessed in clinical studies involving more than 3,000 patients, including an ongoing open-label extension up to five years in duration. Erenumab was the first investigational therapy targeting the CGRP pathway to have received FDA and European Medicines Agency (EMA) regulatory filing acceptance. If approved, it will be administered once-monthly using a self-injection device. Subject to approval, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.