Longboard Pharmaceuticals' Potential Seizure Treatment Gets FDA's Breakthrough Therapy Designation
By Victor Swezey
Longboard Pharmaceuticals has received a breakthrough therapy designation by the U.S. Food and Drug Administration for its potential treatment for certain types of seizures.
The FDA granted the designation to the San Diego-based biopharmaceutical company's bexicaserin to treat seizures tied to developmental and epileptic encephalopathies for patients two years of age or older.
Developmental and epileptic encephalopathies are a group of severe epilepsies defined by potentially drug-resistant seizures and significant developmental delay.
The FDA's breakthrough therapy designation process is intended to accelerate the development and review of drugs for serious or life-threatening conditions which show proof of notably superior results on at least one clinically significant endpoint compared to available therapies.
Chief Medical Officer Randall Kaye said the company intends to initiate phase 3 trials for bexicaserin later this year.
Write to Victor Swezey at victor.swezey@wsj.com
(END) Dow Jones Newswires
July 01, 2024 10:22 ET (14:22 GMT)
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