Aimovig Gets FDA Nod for Preventive Treatment for Migraine

Novel drug is a first-in-class treatment that reduces migraine occurrence

The FDA has approved erenumab-aooe (Aimovig, Amgen, Inc.) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Erenumab 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.

Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura—transient sensory or visual disturbances that appear as flashing lights, zig-zag lines, or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet. Migraine is three times more common in women than in men and affects more than 10% of people worldwide.

The effectiveness of erenumab for the preventive treatment of migraine was evaluated in three clinical trials. The first study included 955 participants with a history of episodic migraine and compared erenumab with placebo. Over the course of six months, erenumab-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 erenumab with placebo. Over the course of three months, erenumab-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 erenumab with placebo. In that study, over the course of three months, patients treated with erenumab experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo.

The most common side effects that patients in the clinical trials reported were injection-site reactions and constipation.

Source: FDA; May 17, 2018.