FDA Approves Aimovig, A Novel Preventive Treatment for Migraine Headaches
by Editro 6/2018
According to Dr. Jessica Ailani, MD, associate professor of neurology at MedStar’s Georgetown University Hospital and director of the MedStar Georgetown Headache Center, migraines affect over 36 million people in the U.S. yet they are still a poorly recognized and under-diagnosed disease. In 2018, the number of migraine-specific treatments available in the US will double compared to what was available 2 decades ago.
The U.S. Food and Drug Administration has now approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. According to Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research “We need new treatments for this painful and often debilitating condition, and Aimovig provides patients with a novel option for reducing the number of days with migraine.”
The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. The first study included 955 participants with a history of episodic migraine. Over the course of six months Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo. The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. Over the course of three months, Aimovig-treated patients experienced, on average, one fewer migraine day per month than those on placebo. The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo. In that study, over the course of three months, patients treated with Aimovig experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo.
Overall Aimovig was very well tolerated and the most common side effects that patients in the clinical trials reported were injection site reactions and constipation.