Harmony Biosciences Holdings, Inc. 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. In 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 Petition did not provide information that changes that assessment.

The 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 review of these materials and for the reasons stated, the Petition is denied.