Harmony Biosciences announced that the U.S. Food and Drug Administration approved its supplemental new drug application for WAKIX® (pitolisant) tablets to treat cataplexy in pediatric patients six years of age and older with narcolepsy. The approval, granted on February 17, 2026, expands the drug’s indication beyond the adult population and makes WAKIX the first and only FDA‑approved non‑scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Prior to this approval, WAKIX had received FDA clearance for excessive daytime sleepiness (EDS) in adults in August 2019, for cataplexy in adults in October 2020, and for EDS in pediatric patients in June 2024. The new pediatric cataplexy indication therefore completes a full spectrum of narcolepsy indications for the product, allowing clinicians to prescribe WAKIX for all major narcolepsy symptoms across age groups.
The expanded indication broadens Harmony’s addressable market and strengthens its competitive moat. As the only non‑scheduled narcolepsy therapy, WAKIX offers clinicians and patients a treatment option that does not require the restricted distribution programs associated with controlled‑substance drugs such as gamma‑hydroxybutyrate. The approval also positions Harmony to capture a larger share of the growing narcolepsy market, potentially increasing sales volume and extending the commercial life of its flagship product.
"We are excited to achieve this important milestone for pediatric narcolepsy patients who experience cataplexy. With this approval, clinicians now have the option to prescribe WAKIX to treat excessive daytime sleepiness, cataplexy, or both, in patients 6 years and older with narcolepsy," said Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer. "WAKIX is now the first‑and‑only FDA‑approved treatment option for both pediatric and adult narcolepsy patients with or without cataplexy that is not scheduled as a controlled substance, an important distinction that supports its clinical utility. We continue to advance our efforts toward obtaining pediatric exclusivity for WAKIX, which, if granted, would add an additional six months of regulatory exclusivity for this growing franchise. Our sights are now set on further growing, extending and expanding the value of pitolisant through additional indications with our next‑generation formulations, which have utility patents filed out to 2044," added Jeffrey M. Dayno, M.D., President and Chief Executive Officer.
The company is pursuing pediatric exclusivity, which could add an extra six months of market protection, and is developing next‑generation formulations and additional indications such as Prader‑Willi syndrome and idiopathic hypersomnia. With utility patents extending to 2044, Harmony aims to sustain long‑term growth and maintain its leadership position in the narcolepsy treatment landscape.
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