FDAnews
www.fdanews.com/articles/178726-amgens-erenumab-reduces-monthly-migraine-days-in-phase-iii-trial

Amgen’s Erenumab Reduces Monthly Migraine Days in Phase III Trial

October 6, 2016

A Phase III placebo-controlled study of erenumab met its primary endpoint, reducing the number of migraine days by nearly three days per month after 12 weeks.

The study, sponsored by Amgen, enrolled 577 patients randomized to receive either placebo or erenumab 70 mg subcutaneously, once monthly. Patients were experiencing between four and 14 migraine days each month, with an average of eight migraine days per month at baseline.

Amgen expects to complete a second Phase III episodic migraine study, evaluating both 70 mg and 140 mg doses for 24 weeks, by the end of the year. Erenumab is being co-developed by Amgen and Novartis; Amgen retained commercialization rights in the U.S., Canada and Japan, while Novartis has rights in Europe and the rest of the world.

View today's stories