Amgen, Novartis migraine drug meets primary endpoint in Phase II study

pharmafile | June 9, 2016 | News story | Research and Development |  AMG 334, Amgen, Novartis, Phase II, chronic, erenumab, migraine 

A new treatment for chronic migraine prevention, co-developed by Novartis (NYSE: NVS) and Amgen (NASDAQ: AMGN), showed a statistically significant reduction in the number of monthly migraine days versus placebo in a Phase II trial.

AMG 334 (erenumab) is a fully human monoclonal antibody that targets the receptor of calcitonin-gene-related-peptide (CGRP) to inhibit its activity. It is believed that CGRP transmits signals that can cause pain.

In the study, 667 patients were randomised to receive AMG 334 (at either 70mg or 140mg) or placebo. The drug met the primary outcome measure of change in monthly migraine days from a baseline of 18 days. Patients taking AMG 334 experienced a mean 6.6 day reduction from this baseline compared to 4.2 days with the placebo.

Vasant Narasimhan, chief medical officer at Novartis, says: “We are delighted that with this positive outcome, we are one step closer to providing patients with a much-needed new treatment option to prevent chronic migraine. Also, we are looking forward to assessing the benefit of AMG 334 in two ongoing phase III studies in episodic migraine, with initial data from these studies expected later this year.”

As part of this co-development collaboration, Amgen retains commercialisation rights to AMG 334 in the US, Canada and Japan while Novartis has commercialisation rights in Europe and the rest of the world.

Sean Murray