FDA Approves Third Injectable Migraine Drug

By Pat Anson, PNN Editor

Migraine sufferers will soon have another treatment option. Eli Lilly has announced that the U.S. Food and Drug Administration has approved Emgality (galcanezumab), a monthly self-injected drug for the prevention of migraine in adults.

Emgality is the third injectable migraine drug the FDA has approved this year. In May, the agency gave approval to Amgen’s Aimovig (erenumab), the first migraine drug that uses fully human monoclonal antibodies to target receptors in the brain where migraines are thought to originate.  Last week, the FDA approved Teva’s Ajovy, a migraine prevention drug that can be injected monthly or quarterly.

Lilly said the efficacy and safety of Emgality was demonstrated in three Phase 3 clinical trials in patients with episodic or chronic migraine.

Emgality reduced the number of monthly migraine headache days by an average of 4.7 days in patients with episodic migraine and by 4.8 days in patients with chronic migraine.  

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, as well as sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

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“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”

Lilly said Emgality would be available “shortly” at a listed price of $575 for a single injection or $6,900 annually. That introductory price is identical to that of Aimovig and Ajovy, although various discounts or rebates could make the cost lower. Lilly said it would offer Emgality for up to 12 months free to patients with commercial insurance under its patient assistance program.   

“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible,” said Shaw.

Earlier this month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion of Emgality for the prevention of migraine in adults who have at least four migraine days per month. That positive opinion was referred for final action to the European Commission, which grants drug approval in the European Union.