Amgen/Novartis migraine candidate meets endpoints in unique Phase IIIb study

Swiss pharma giant Novartis (NOVN: VX) late yesterday announced positive results from the Phase IIIb LIBERTY study assessing the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects.

The study met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo.LIBERTY also met all secondary endpoints including: reduction of monthly migraine days, reduction in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo.) The safety data are consistent with previous studies of erenumab to date, showing a placebo-like safety profile. Full data will be presented at an upcoming scientific meeting.

Under the proposed trade name Aimovig, the drug was accepted for review by the US Food and Drug Administration in July last year, with a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018, and, if approved, Aimovig will be jointly commercialized in the USA by Novartis and US biotech major Amgen (Nasdaq: AMGN).