Novartis today announced that results reinforcing the long-term safety and efficacy profile of Aimovig (erenumab-aooe) in patients with episodic migraine (EM) are being presented at the Migraine Trust Virtual Symposium. Results from the five-year, open-label treatment period of a Phase 2 study in episodic migraine prevention showed Aimovig helped patients achieve sustained reductions in monthly migraine days (MMD) and in use of acute migraine-specific medication, such as triptans. Additionally, the safety profile was consistent with what was observed in the double-blind treatment phase of the study, with no increases in adverse event rates over five years of exposure.1

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

The five-year, open-label treatment phase enrolled 383 patients with episodic migraine who completed a 12-week double-blind, placebo-controlled treatment period (DBTP). Among the 216 patients who completed the open-label treatment phase, there was an average MMD reduction of 5.3 days from the DBTP baseline of 8.7 days. By the end of the study, patients who used AMSM to treat their migraine headaches experienced an average reduction in AMSM use of 4.4 days from the DBTP baseline of 6.2 days. The most common side effects were nasopharyngitis, upper respiratory tract infection and influenza.

"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, and demonstrate progress for the millions of patients who may be candidates for preventive migraine treatment," said Victor Bultó, President, Novartis Pharmaceuticals Corporation. "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."

Additional studies highlighting Aimovig will be presented at the Migraine Trust Virtual Symposium, including interim results of the LIBERTY open-label extension study as well as efficacy and safety results of Aimovig in the EMPOwER study. These studies reinforce the efficacy and safety profile of Aimovig for patients of various backgrounds across the episodic migraine spectrum.