Novartis’ Aimovig yields positive data in open label period

2nd July 2019 (Last Updated August 8th, 2019 14:27)

Novartis has reported that its Aimovig (erenumab) medicine reduced the number of monthly migraine days (MMD) during the open-label extension phase of the LIBERTY Phase IIIb clinical trial.

Novartis’ Aimovig yields positive data in open label period
MOMENTUM will only involve patients who experienced inadequate response to prior migraine treatments. Credit: r. nial bradshaw.

Novartis has reported that its Aimovig (erenumab) medicine reduced the number of monthly migraine days (MMD) during the open-label extension phase of the LIBERTY Phase IIIb clinical trial.

A 140mg dose of the drug was also observed to decrease migraine-specific medication days (MSMD). It was found to lead to rapid improvement on all efficacy parameters at weeks 13-16 and 21-24.

Patients also showed improvements in physical impairment outcomes and ability to participate in everyday activities.

Novartis Pharmaceuticals Neuroscience Development global head Danny Bar-Zohar said: “This new set of data results underline the long-term efficacy of Aimovig for patients who have struggled to find effective preventive therapies specifically designed for migraine.

“Being able to propose additional solutions, such as Aimovig, for patients with prior preventive treatment failures is key to help them get their lives back.”

Aimovig is a migraine prevention medication that specifically blocks the calcitonin gene-related peptide receptor (CGRP-R).

LIBERTY is a multi-centre, randomised, double-blind, placebo-controlled trial designed to assess the safety and efficacy of erenumab for the treatment of episodic migraine in patients who failed two to four prior preventive therapies for the condition.

The 246-patient study comprises a 12-week double-blind treatment phase and an ongoing 156-week open-label extension phase.

The primary endpoint of the double-blind phase was the proportion of participants with at least a 50% decrease in monthly migraine days from baseline over weeks nine to 12.

During the period, the trial also tracked the change in monthly migraine days, the number of monthly acute migraine-specific medication treatment days, the Migraine Physical Function Impact Diary (MPFID) physical impairment, and impact on daily activities domain scores as secondary endpoints.

Intended to evaluate the long-term efficacy of the drug, the open-label extension phase enrolled subjects who completed the double-blind phase.

Novartis further reported that 70mg and 140mg doses of Aimovig significantly reduced MMD and MSMD in a Phase III STRIVE trial involving episodic migraine patients.