A “novel” new preventative treatment for migraines in adults, which works by blocking the activity of a molecule involved in migraine attacks, has been approved by the US Food and Drug Administration (FDA). Approval for Aimovig (erenumab-aooe) was granted to Amgen Inc following three clinical trials evaluating the efficacy of the drug.
Migraine is the third most common disease in the world, affecting an estimated 38 million people in the United States alone. Aimovig, administered via self-injection once each month, is the first preventative migraine treatment that works by blocking the action of calcitonin gene-related peptide (CGRP) molecule. Eric Bastings, MD, deputy director of neurology products at the FDA’s Center for Drug Evaluation and Research described the drug as a “novel option” for reducing monthly migraine days.
The first two clinical trials, conducted over six and three months respectively, compared the efficacy of Aimovig with a placebo drug in patients with a history of episodic migraines. Patients given Aimovig in the first trial experienced, on average, between one and two fewer migraine days each month compared to those given a placebo, while patients given the Amgen drug in the second trial experienced one less migraine day.
The third trial demonstrated that Aimovig-treated patients with chronic migraine given the medication over three months experienced 2.5 fewer migraine days than those administered with a placebo. The most common side effects experienced by patients in the trials were injection site reactions and constipation.
Migraines are moderate to severe headaches and are sometimes accompanied by other symptoms, such as nausea, vomiting, light sensitivity, and sensitivity to sound. The most common symptom, experienced by 85 percent of migraine sufferers, is a throbbing or pulsating pain in the side of the head, according to figures from the American Migraine Study II. The second most common is light sensitivity, which is experienced by eight out of ten patients.
There are several different forms of migraine, but the most common is migraine without aura, which occurs without any specific warning signs. Patients who suffer from migraines with auras often experience temporary sensory or visual disturbances (auras) which precede that attack. Migraines may have a variety of triggers, including hormonal changes, bright or flashing lights, stress, sleep or food deprivation, and diet. A variety of drugs to prevent migraines or alleviate the symptoms are currently available, including Cambia (diclofenac) and Topamax (topiramate).
Earlier this year, the board of directors of the American Migraine Foundation submitted comments on CGRP drugs to the Institute for Clinical and Economic Review. They described this new class of medications as “a major, indeed groundbreaking advance in the preventative treatment of migraine”.
“The efficacy and very favorable tolerability profile of these biologics increase the likelihood that patients can adhere to and comply with the therapy and therefore receive long-term benefit and improved health care outcomes,” the statement concluded.