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HARMONY BIOSCIENCES ACKNOWLEDGES U.S. FOOD & DRUG ADMINISTRATION (FDA) ACTION DENYING THE CITIZEN PETITION FOR WAKIX® (PITOLSIANT)
FDA confirms the favorable benefit-risk profile of WAKIX Harmony Biosciences focused on continuing to advance its pipeline assets across three rare CNS
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"FDA confirms the favorable benefit-risk profile of WAKIX\nHarmony Biosciences focused on continuing to advance its pipeline assets across three rare CNS franchises; anticipates at least one new product or indication launch annually over the next five years\nPLYMOUTH MEETING, Pa., June 25, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that the U.S. Food and Drug Administration denied the Citizen Petition filed by a short seller claiming that WAKIX is not safe and effective for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. 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.\n\n \n \n \n \n \n \n\n \nIn its denial, the FDA rejected all three requests from the Petitioner including withdrawal for all indications, immediate alert distribution ('Dear HCP Letter') to prescribers, and transitioning to a Compassionate Use Program with a REMS protocol, and 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.\"1\nThe FDA denied the Petition after approving the supplemental New Drug Application (sNDA) for WAKIX on June 21, 2024, which expanded the indication for WAKIX to include the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. The denial letter states, \"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.\"2\nHarmony Biosciences stated:\n\"We are pleased with the FDA's decision to deny the short seller Petition filed in March 2023, which tried to cast doubt on a safe and effective treatment while deliberately attempting to impact our stock price for profit. 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. \nLooking ahead, we confirm our outlook that WAKIX represents a billion-dollar plus market opportunity in adult narco...