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The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
On May 17, 2018, FDA announced approval of Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. According to the agency, Aimovig is the first FDA-approved preventive migraine treatment that works by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in an agency press release. “We need new treatments for this painful and often debilitating condition.”
The drug was evaluated in three clinical trials. In Phase II and III studies in chronic and episodic migraine, the drug resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo.
"Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart J. Tepper, MD, professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School, in a press statement . "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy–with a discontinuation rate of two percent due to adverse eventsÂ and experienced sustained migraine prevention."
The drug is the result of an August 2015 collaboration between Amgen and Novartis to develop and commercialize treatments for migraine and Alzheimer's disease. The collaboration focuses on Amgen’s investigational drugs for migraine, including AMG 301, a human monoclonal antibody that inhibits the pituitary adenylate cyclase-activating polypeptide type 1 (PAC1) receptor, currently in Phase II development.
In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the United States. Amgen retains exclusive commercialization rights for the migraine programs in the US (except for Aimovig) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada, and the rest of world.
Additionally, the companies are partnering in the development and commercialization of a beta-secretase 1 inhibitor program in Alzheimer's disease. The oral therapy CNP520, currently in Phase III for Alzheimer's disease, is the lead molecule, and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.
Aimovig is currently under review by the European Medicines Agency. The companies state that they expect approval in the European Union within the coming months.