Amgen’s Novel Migraine Treatment Gets Key Approval

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Amgen Inc. (NASDAQ: AMGN) shares saw a nice bump after the U.S. Food and Drug Administration (FDA) on Thursday approved Aimovig (erenumab), Amgen’s preventive treatment of migraine in adults. It is the first FDA-approved preventive migraine treatment in a new class of drugs, which work by blocking the activity of calcitonin gene-related peptide, which is believed to play a critical role in migraine attacks.

Aimovig’s effectiveness in preventing migraines was evaluated in three clinical trials. The first two studies compared Aimovig to placebo in participants with a history of episodic migraine. Patients receiving Aimovig on average experienced one or two fewer monthly migraine days than those on placebo. The third study evaluated patients with a history of chronic migraine. Patients in that study treated with Aimovig averaged two and a half fewer monthly migraine days in three months than those receiving placebo.

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

Preventive medications may be an option for around 8 million Americans suffering from migraine, Amgen said. Aimovig, which is given monthly by self-injection, will have a list price of $6,900 a year, or $575 a month, the company also said. Last week, President Donald Trump blasted drugmakers and health care “middlemen” for making prescription medicines unaffordable for Americans. Amgen, which will market Aimovig in partnership with Novartis A.G. (NYSE: NVS), said the drug’s price “reflects the value it brings to patients and society.”

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Eli Lilly & Co. (NYSE: LLY) are among companies developing similar treatments.

Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School, said:

Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success.

Shares of Amgen were up almost 2% at $177.56 in Friday’s premarket, with a consensus analyst price target of $194.33 and a 52-week trading range of $152.16 to $201.23.

Novartis and Teva shares were up marginally in early indications as well.