Amgen announced positive top-line results from their Phase 3 trial ARISE, evaluating erenumab (AMG 334) for safety and efficacy in preventing migraines.

Erenumab is a subcutaneously-administered, fully human monoclonal antibody that targets and blocks the Calcitonin Gene-Related Peptide (CGRP) receptor, thought to be pivotal in the genesis of migraine. 

The trial, entitled ARISE, included a total of 577 patients who were randomized to receive either placebo or erenumab 70mg subcutaneously, once monthly. At baseline, the average migraine days per month were 8. After 12 weeks of the trial, those in the erenumab group had a statistically significant 2.9-day reduction in monthly migraine days compared with a 1.8-day reduction in the placebo arm. 

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“These positive results, along with the recent chronic migraine results, contribute to the growing body of evidence supporting erenumab as an innovative treatment option,” said Sean E. Harper, MD, executive  vice president of research and development for Amgen.

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

A second Phase 3 study (‘STRIVE’) evaluating 70mg and 140mg doses for 24 weeks is expected to be completed by the end of the year.

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