- A Phase 3 clinical trial, STRIVE, assessing Amgen's (NASDAQ:AMGN) erenumab (AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid change from baseline in mean monthly migraine days at week 24 compared to placebo.
- STRIVE randomized participants to receive either 70 mg or 140 mg of erenumab or placebo administered subcutaneously once per month for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. At week 24, the average reductions in migraine days per month for the 70 mg, 140 mg and placebo arms were 3.2, 3.7 and 1.8, respectively.
- Erenumab's safety profile was comparable to placebo and was consistent with previous studies. The most common adverse events were nasopharyngitis, upper respiratory infection and sinusitis.
- The analysis of the data is ongoing. Detailed results will be submitted for publication and for presentation at a future medical conference.
- It was also successful in another Phase 3 study called ARISE. Regulatory submissions are on tap for 2017.
- Erenumab, a fully human monoclonal antibody, inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. It is being co-developed with Novartis (NYSE:NVS). Amgen retains commercial rights in the U.S., Canada and Japan and Novartis has commercial rights elsewhere.
- Shares are up 1% after hours on average volume.
- Previously: Amgen's erenumab (AMG 334) successful in late-stage study in migraine prevention (Sept. 28)
Original article