A global phase 3 study of erenumab (Amgen and Novartis) showed that the drug was able to prevent migraines headaches.
The study met the primary end point, 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, according to an Amgen statement.
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 under-diagnosed and under-treated. People who experience migraine battle the disease for many years and it has significant impact on their everyday activities," said Sean E. Harper, MD, executive vice president of research and development at Amgen.
Patients enrolled in the phase 3 STRIVE study were randomized to receive either placebo or 1 of 2 erenumab doses-70 mg or 140 mg-subcutaneously, once monthly for 6 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, as compared to a 1.8-day reduction in the placebo arm. These results were statistically significant, according to an Amgen statement.
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.
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 together, almost 2,200 patients with chronic and episodic migraine have participated in these 3 erenumab clinical trials.
“These data will help support discussions with regulatory agencies, with filing anticipated in 2017,” according to an Amgen statement.
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