FDA approves novel preventive treatment for migraine

FDAThe 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.

Most Popular Now

Bayer Thrombosis Research Award 2019 goes to Dr. C…

The fourth winner of the Bayer Thrombosis Research Award has been chosen. The Scientific Committee of the Bayer Science & Education Foundation awarded the EUR 30,000 priz...

Roche enters into definitive merger agreement to a…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeuti...

Brilinta’s Phase III THEMIS trial met primary endp…

The Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant red...

Jury upholds Amgen's patents on Repatha® (evolocum…

Amgen (NASDAQ:AMGN) announced that a Delaware jury delivered a verdict in Amgen's favor upholding the validity of two Amgen patents related to PCSK9 antibodies. These pat...

Protein content as a marker for response to therap…

Brain tumors vary widely in how they respond to treatment. However, early assessment of therapy response is essential in order to choose the best possible treatment for t...

Artificial lung cancer tissue could help find new …

A 3D hydrogel created by researchers in U of T Engineering Professor Molly Shoichet's lab is helping University of Ottawa researchers to quickly screen hundreds of potent...

Could medical marijuana help grandma and grandpa w…

Medical marijuana may bring relief to older people who have symptoms like pain, sleep disorders or anxiety due to chronic conditions including amyotrophic lateral scleros...

New treatment offers potentially promising results…

A pioneering clinical trials program that delivered an experimental treatment directly to the brain offers hope that it may be possible to restore the cells damaged in Pa...

Amgen, Cytokinetics and Servier announce start of …

Amgen (NASDAQ: AMGN), Cytokinetics, Incorporated (NASDAQ: CYTK) and Servier today announced that METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecar...

Could blockchain ensure integrity of clinical tria…

UC San Francisco researchers have created a proof-of-concept method for ensuring the integrity of clinical trials data with blockchain. The system creates an immutable au...

Novartis data confirm rapid response and high effi…

Novartis announced today new data in 441 Chinese patients with moderate to severe plaque psoriasis from a Phase III study investigating the efficacy and safety of Cosenty...

Abbott and Novo Nordisk enter partnership to provi…

Abbott and Novo Nordisk today announced a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly...