FDA Denies Petition Challenging Safety and Efficacy of Harmony Biosciences’ Drug

Harmony Biosciences Holdings

PLYMOUTH MEETING, PAHarmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) recently denied a Citizen Petition filed by a short seller. The petition had claimed that WAKIX, a drug used to treat excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, was not safe or effective.

The FDA’s decision comes as no surprise to Harmony Biosciences. “The Agency’s decision to reject the Petition was anticipated and confirms the Company’s long-held position that the allegations in the Petition were unfounded and without merit,” said the company in a statement.

In its denial, the FDA dismissed all three requests made by the petitioner. These included withdrawing the drug for all indications, issuing an immediate alert to prescribers, and transitioning to a Compassionate Use Program with a Risk Evaluation and Mitigation Strategy (REMS) protocol. The FDA stated, “the FDA determined that WAKIX has a favorable benefit-risk profile under its approved conditions of use, and your Petition did not provide information that changes that assessment.”

The regulatory body issued the denial after approving a supplemental New Drug Application (sNDA) for WAKIX on June 21, 2024. This approval expanded the drug’s use to include treating EDS in pediatric patients aged 6 years and older with narcolepsy. In its denial letter, the FDA noted, “the FDA has carefully considered the information submitted in the Petition, other data available to the Agency, and relevant published literature. Based on our review of these materials and for the reasons stated, the Petition is denied.”

Harmony Biosciences can now focus on continuing to provide WAKIX to patients who need it, bolstered by the FDA’s reaffirmation of the drug’s safety and efficacy.

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