Novartis reports erenumab met all primary and secondary endpoints in unique Phase IIIb study in episodic migraine patients who have failed multiple prior preventive treatments

Novartis International AG / Novartis reports erenumab met all primary and secondary endpoints in unique Phase IIIb study in episodic migraine patients who have failed multiple prior preventive treatments . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• LIBERTY is the first migraine prevention trial of its kind conducted specifically in patients who have tried multiple therapies without success, and are in need of additional treatment options
   

The trial met its primary endpoint of percentage of patients on erenumab (AMG 334) achieving at least a 50% reduction of migraine days versus placebo, and all secondary endpoints
 

Statistically significant and clinically meaningful results add to the consistent efficacy and placebo-like safety profile of erenumab seen across the spectrum of migraine, even in more difficult-to-treat patients

Basel, January 22, 2018 - Novartis today 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.

"The LIBERTY trial is the only Phase IIIb anti-CGRP study to demonstrate safety and efficacy in patients who have repeatedly failed other preventive treatments," said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis. "The results add to the consistent body of evidence for erenumab across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years. We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."