Novartis reports positive results for Aimovig in phase 2 episodic migraine trial

Novartis said that a five-year phase 2 clinical trial of migraine prevention drug Aimovig (erenumab-aooe) has delivered strong long-term safety and efficacy results in patients with episodic migraine (EM).

The results of the mid-stage trial – NCT01952574 are being presented by the Swiss drugmaker at the 18th Migraine Trust Virtual Symposium.

The five-year, open-label treatment period of the phase 2 clinical study in episodic migraine prevention proved that Aimovig helped patients in experiencing sustained reductions in monthly migraine days (MMD) and also in their use of acute migraine-specific medication (AMSM) like triptans.

Apart from that, the safety profile of the migraine drug candidate was on par with what was noted in the double-blind treatment phase of the study, with no increases in adverse event rates during five years of exposure, said Novartis.

Dr. Messoud Ashina – Professor of Neurology in the Faculty of Health and Medical Sciences at the University of Copenhagen said: “These important data highlight the sustained efficacy, safety and tolerability profile of Aimovig, and provide crucial information for patients and doctors managing migraine.

“The study reinforces the potential of Aimovig to reduce monthly migraine days over the long term for people living with this debilitating, yet underdiagnosed disease. For my patients, more migraine-free days means they’re able to get back to the things that are important to them, like spending more time with family and friends, and being able to go to work.”

Novartis reports positive results for Aimovig in phase 2 episodic migraine trial. Photo courtesy of Novartis AG.

The phase 2 open-label trial had featured 383 patients having episodic migraine who completed a 12-week double-blind, placebo-controlled treatment period (DBTP).

Among the 216 patients who had finished the open-label treatment phase, the average MMD reduction was 5.3 days from the DBTP baseline of 8.7 days.

Patients, who used acute migraine-specific medication for the treatment of their migraine headaches, by the end of the study, had experienced an average reduction in acute migraine-specific medication use of 4.4 days from the DBTP baseline of 6.2 days.

Nasopharyngitis, upper respiratory tract infection, and influenza were among the most common side effects of Aimovig in the phase 2 study.

Victor Bultó – President of Novartis Pharmaceuticals said: “These long-term results signify a big step for people affected by this debilitating neurological disease, many of whom live in dread of the next attack,3 and demonstrate progress for the millions of patients who may be candidates for preventive migraine treatment.

“As the first FDA-approved treatment and most prescribed preventive therapy in the calcitonin gene-related peptide class of medications, Aimovig represents Novartis’ strong heritage and ongoing commitment to research and development to better support patients.”

Aimovig, which is co-marketed by Amgen and Novartis in the US, is the first and only approved migraine preventive treatment in the US and the European Union that has been designed to target the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.