# FDA Approves Harmony Biosciences' WAKIX for Narcolepsy Treatment Harmony Biosciences announced FDA approval of WAKIX (pitolisant hydrochloride), an oral histamine H3-receptor antagonist for narcolepsy, positioning the company as a key player in the rare neurological disease market and opening a new therapeutic category for a condition affecting approximately 135,000 Americans. The approval establishes WAKIX as the first and only non-controlled treatment option for narcolepsy, potentially capturing significant market share from existing controlled-substance alternatives and driving substantial