Positive top-line phase 3 results have been achieved for erenumab in the global, randomized, double-blind, placebo-controlled STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion (STRIVE), Amgen reports. These data showed STRIVE met the primary endpoint, demonstrating statistically significant reductions from baseline in monthly migraine days in patients with episodic migraine treated with either 70 mg or 140 mg of erenumab compared with placebo. 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.
Migraine is ranked one of the most debilitating diseases by the World Health Organization, yet it is often underdiagnosed and undertreated. The disease has significant impact on people’s everyday activities.
Patients enrolled in the STRIVE trial were randomized to receive either placebo or one of two erenumab doses (70 mg or 140 mg) subcutaneously, once monthly for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. Patients in the erenumab 70-mg and 140-mg treatment arms experienced reductions of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, compared with a 1.8-day reduction in the placebo arm. These results were statistically significant.
The safety profile of erenumab was comparable to placebo across both treatment arms and was consistent with previously reported studies. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection, and sinusitis.
Further analysis of STRIVE data is ongoing and will be submitted to a future medical conference and for publication.
Two other positive trials—ARISE, a phase 3 study of erenumab in episodic migraine prevention, and the phase 2 study of erenumab in chronic migraine prevention—were announced earlier this year. Combined, almost 2,200 patients with chronic and episodic migraine have participated in the three erenumab clinical trials. These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
Erenumab is being codeveloped 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 rest of world.
Source: Amgen; November 17, 2016.