Lilly Submitting Applications For Headache Treatments

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INDIANAPOLIS -

Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has submitted an application to the U.S. Food and Drug Administration for a new drug to treat migraine headaches. Lasmiditan would be used for the acute treatment of certain types of migraines in adults. 

Lilly says the drug is distinct from other approved migraine treatments due to its lack of any narrowing effect on blood vessels, and is the first and only in its class to be evaluated for acute treatment of migraines in adults. The company says an approval could mean the first significant treatment of migraines in more than two decades.

Lilly also plans to submit an application for the cluster-headache treatment drug Emgality by the end of the year. The FDA granted Breakthrough Therapy Designation for the drug, which is used to speed up the development and review of drugs to treat life-threatening diseases. There are no current treatments for episodic cluster headaches in the country.

"Headache disorders like migraine and cluster headache affect each person differently, and many patients spend years cycling through different medications to effectively diagnose and treat their symptoms," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines. "Lilly has spent the last 25 years researching innovative therapies to treat headache disorders, and we are thrilled to be one step closer to potentially providing new and different options with lasmiditan for the acute treatment of migraine and Emgality for the preventive treatment of episodic cluster headache."

The drugs are two of three in Lilly's pain treatment portfolio, which also includes Tanezumab, which was developed with Pfizer and is currently being investigated to treat pain from osteoarthritis, lower back and cancer. 

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