Novartis has reported positive results in the LIBERTY trial, a Phase IIIb study investigating the safety and efficacy of Aimovig (erenumab) in patients with episodic migraine who had previously failed two to four preventive treatments for migraine.
The double-blind, placebo-controlled trial enrolled 246 patients.
As part of the trial, patients were randomised to receive monthly subcutaneous injections of either erenumab 140mg or placebo for 12 weeks.
The trial’s 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.
Its secondary endpoints comprised change from baseline in monthly migraine days, in the number of monthly acute migraine-specific medication treatment days, and in the Migraine Physical Function Impact Diary (MPFID) physical impairment and impact on everyday activities domain scores.
They also included percentages of patients with a 75% and 100% response rate to erenumab, as well as safety and tolerability of the drug.
The trial also features an ongoing 52 week open-label extension study.
Novartis Neuroscience Development global head Danny Bar-Zohar said: “In LIBERTY, all primary and secondary endpoints were met.
“These data, combined with the previously reported positive results, further reinforce erenumab’s robust efficacy and safety profile seen across the full spectrum of migraine.”
Erenumab has been specifically designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays an important role in migraine activation.