THOUSAND OAKS (dpa-AFX) - Amgen (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 or 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 or CGRP receptor, which is believed to have a critical role in mediating the incapacitating pain of migraine.
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.
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