Amgen (AMGN) Announces Erenumab Phase 3 Met Primary Endpoint in Migraine Prevention

September 28, 2016 4:31 PM EDT

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Amgen (Nasdaq: AMGN) announced positive top-line results for erenumab (AMG 334) from A Phase 3, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention (ARISE). These data showed the ARISE study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab compared with placebo at 12 weeks. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of migraine.

"People with episodic migraine lose a substantial part of their lives to migraine, and many face intolerable pain and physical impairment, frequently accompanied by a significant disruption of their daily activities. Unfortunately, there are limited preventive treatment options currently available for these patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These positive results, along with the recent chronic migraine results, contribute to the growing body of evidence supporting erenumab as an innovative treatment option for people who are suffering from this debilitating disease."

A total of 577 patients were randomized to receive either placebo or erenumab 70 mg subcutaneously, once monthly. Patients enrolled in the ARISE study were experiencing between four and 14 migraine days each month, with an average of eight migraine days per month at baseline. Those receiving erenumab experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm.

The safety profile of erenumab was similar to placebo and consistent with previously reported studies. The most common adverse events were upper respiratory tract infection, injection site pain and nasopharyngitis.

Further analysis of these data is ongoing and will be submitted to a future medical conference and for publication. The STRIVE* study, a second Phase 3 episodic migraine study evaluating both 70 mg and 140 mg doses for 24 weeks, is expected to be completed by the end of this year. Positive results from a Phase 2 study of erenumab in chronic migraine prevention were also announced earlier this year.

Erenumab is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and the rest of the world.

*STRIVE is a Phase 3, randomized, double-blind, placebo-controlled STudy to Evaluate the Efficacy and Safety of AMG 334 in MigRaIne PreVEntion.

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