FDA: The U.S. Food and Drug Administration today 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.“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said 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.”
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 percent of people worldwide.
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 and compared Aimovig to
placebo. 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.
The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.
The FDA granted the approval of Aimovig to Amgen Inc.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.