FDA News

FDA approves novel migraine prevention treatment

The FDA has approved the monthly self-injectable treatment Aimovig for preventing migraines in adults, according to a press release.

Aimovig (erenumab-aooe, Amgen) is the first such treatment approved by the FDA that blocks the activity of the calcitonin gene-related peptide molecule that causes migraines. Patients will receive either a 70-mg or 140-mg dose of erenumab-aooe a month, Novartis, who collaborated with Amgen to develop the drug, stated in the release.

A FDA press release indicated erenumab-aooe was effective in three trials involving 2,199 patients with migraines, with each trial producing anywhere from 1 to 2.5 fewer migraine- free days per month vs. placebo. The first two trials consisted of patients with episodic migraine and the last trial's patients had chronic migraine. 

The most common adverse events in patients in clinical trials were constipation and injection site reactions, the FDA press release stated.

The FDA has approved the monthly self-injectable treatment Aimovig for preventing migraines in adults, according to a press release. Photo Source: Shutterstock

“Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine,” Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School said in a release. “Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success.”

The list price of erenumab-aooe is $575 for a 70-mg or 140-mg single-use prefilled SureClick (Amgen) autoinjector in the United States, but the final cost for patients would depend on insurance, Novartis stated. The company also indicated the drug should be available to patients in the U.S. within a week. European approval is pending.

“For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease,” Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients said in a press release.

“Today, we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days.”

Disclosures: Healio Family Medicine was unable to confirm relevant financial disclosures prior to publication.

The FDA has approved the monthly self-injectable treatment Aimovig for preventing migraines in adults, according to a press release.

Aimovig (erenumab-aooe, Amgen) is the first such treatment approved by the FDA that blocks the activity of the calcitonin gene-related peptide molecule that causes migraines. Patients will receive either a 70-mg or 140-mg dose of erenumab-aooe a month, Novartis, who collaborated with Amgen to develop the drug, stated in the release.

A FDA press release indicated erenumab-aooe was effective in three trials involving 2,199 patients with migraines, with each trial producing anywhere from 1 to 2.5 fewer migraine- free days per month vs. placebo. The first two trials consisted of patients with episodic migraine and the last trial's patients had chronic migraine. 

The most common adverse events in patients in clinical trials were constipation and injection site reactions, the FDA press release stated.

The FDA has approved the monthly self-injectable treatment Aimovig for preventing migraines in adults, according to a press release. Photo Source: Shutterstock

“Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine,” Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School said in a release. “Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success.”

The list price of erenumab-aooe is $575 for a 70-mg or 140-mg single-use prefilled SureClick (Amgen) autoinjector in the United States, but the final cost for patients would depend on insurance, Novartis stated. The company also indicated the drug should be available to patients in the U.S. within a week. European approval is pending.

“For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease,” Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients said in a press release.

“Today, we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days.”

Disclosures: Healio Family Medicine was unable to confirm relevant financial disclosures prior to publication.