The Food and Drug Administration (FDA) on Tuesday announced they had signed off on Emgality, an episodic cluster headache treatment that’s the first of its kind to be approved by the federal agency.
The FDA, which initially signed off on the drug in September 2018 as a “preventive treatment of migraine in adults,” gave approval to Eli Lilly, according to a news release.
“Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” Eric Bastings, M.D., the deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said.
A cluster headache was described as one that causes severe pain that “tends to occur in clusters, often at the same times(s) of the day, for several weeks to months,” the FDA said. Among other possible symptoms are bloodshot eyes and facial sweating.
During a clinical trial that included roughly 100 patients, individuals taking the drug had 8.7 fewer weekly cluster headache instances since the beginning versus those taking a placebo who had 5.2 less, the agency said.
The FDA did note the possibility of hypersensitivity reactions when using the treatment, adding that the most common side effect “was injection site reactions.”