Eli Lilly Bags USFDA nod for its migraine drug as first ever cluster headache treatment

NEW YORK: Eli Lilly and Co's migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks, the Food and Drug Administration said.

Emgality belongs to a new class of drugs called CGRP inhibitors that are used to prevent migraines or reduce their frequency. It competes with Ajovy from Teva Pharmaceutical Industries Ltd and Amgen Inc's Aimovig, all approved within months of each other last year, creating a fierce battle for market share. The approval for a second use could help Lilly differentiate Emgality from its rivals.

Cluster headaches are recurring, intense headaches that can occur several times daily during a "cluster period." Lilly estimates that around 250,000 people suffer from the condition in the United States.

"Patients haven't had a lot of other treatment options available, or they have been using stuff that hasn't been approved and shown great evidence to help with episodic cluster headaches," Libby Driscoll, vice president of Lilly's neuroscience business unit, told Reuters.

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The great majority of cluster headache cases are episodic, with attacks occurring in periods that can last from seven days to one year, followed by pain-free remission periods of at least one month.

The rest are classified as chronic, with attacks occurring for more than a year without a remission period, or with remission lasting less than a month.

Unlike migraines, which tend to be more prevalent in women, the condition is slightly more common in men.

The injected treatment is administered once a month for the length of a cluster period, which tend to last two weeks to 10 weeks on average. Cluster headache patients will be given a 300-milligram monthly dose, compared with a 120 mg per month dose for migraine prevention.

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The drug will be priced the same as for migraine on a per milligram basis, but the cost will vary depending on the length of treatment. Emgality for migraines costs $6,900 a year.

Last month, Lilly said it had pulled ahead of Amgen and Teva in attracting new migraine patients. It is seeking to build on that advantage by stressing that its therapy can completely prevent headaches in a small percentage of patients.