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."
Erenumab is the only investigational fully human monoclonal antibody designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. Currently available preventive treatments for migraine have generally been repurposed from other therapeutic areas and are often associated with poor tolerability and lack of efficacy[1].
The safety, efficacy and tolerability of erenumab have been assessed in clinical studies involving more than 3,000 patients, including an ongoing open-label extension up to five years in duration. Erenumab was the first investigational therapy targeting the CGRP pathway to have received Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory filing acceptance. If approved, it will be administered once-monthly using a self-injection device. Subject to approval, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.
About LIBERTY
LIBERTY (NCT03096834) is a Phase IIIb, multicenter, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in patients with episodic migraine (defined in the trial as four to 14 migraine days per month at baseline) who have failed two to four prior preventive treatments for migraine. In the study, 246 participants were randomized to receive erenumab 140mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the percentage of patients with at least 50% reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9-12)[2]. The trial includes an ongoing 52 week open-label extension study.
Secondary endpoints assessed during the same time period included: change from baseline in monthly migraine days, change from baseline in the number of monthly acute migraine-specific medication treatment days, change from baseline in the Migraine Physical Function Impact Diary (MPFID) physical impairment and impact on everyday activities domain scores. The MPFID is a scale developed to measure these two domains. It has been validated in line with US Fo...
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