Aimovig prevents migraines in patients who failed prior treatment
Amgen Inc. (NASDAQ:AMGN) and Novartis AG (NYSE:NVS; SIX:NOVN) said Aimovig erenumab met the primary and all secondary endpoints in the Phase IIIb LIBERTY trial to prevent episodic migraine in patients who failed two to four previous prophylactic treatments. The partners said LIBERTY is the first migraine prevention trial conducted specifically in patients who have tried multiple therapies without success and are in need of additional treatment options. The mAb is under FDA and EMA review to prevent migraine, with a May 17 PDUFA date in the U.S. (see BioCentury Extra, July 20, 2017).
In the 246-patient trial, 140 mg subcutaneous Aimovig given once monthly for three months significantly improved the proportion of patients with at least a 50% reduction from baseline in monthly migraine days vs. placebo. The candidate led to significant improvements over placebo on secondary endpoints measuring monthly migraine days, days requiring rescue medication, Migraine Physical Function Impact Diary (MPFID) scores and the proportion of patients with a 75% or 100% reduction in monthly migraine days...