Harmony Biosciences Says FDA Denies Short Seller Claims Over Narcolepsy Drug Safety

Dow Jones06-25

By Michael Susin

Harmony Biosciences Holdings on Tuesday said the U.S. Food and Drug Administration denied a citizen petition filed by short seller which claimed there were safety issues around its narcolepsy drug, Wakix.

The pharmaceutical company said the FDA rejected the petition which claimed Wakix was neither safe nor effective for the treatment of excessive daytime sleepiness, or EDS, and cataplexy in adults with narcolepsy. The denied requests also included the withdrawal for all indications and an immediate alert distribution to prescribers.

The company said the regulator didn't receive information which changed the favorable benefit-risk profile of the drug.

On Friday the FDA expanded Wakix's indication to include the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy

"We appreciate the agency's careful review of the unfounded claims in the petition and its definitive action to deny the claims and resolve any potential doubt about the favorable benefit-risk profile of Wakix," the company said.

Write to Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

June 25, 2024 09:43 ET (13:43 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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