Harmony Biosciences announced that the FDA has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome, or PWS. Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with excessive daytime sleepiness. In the upcoming Phase 3 registrational TEMPO study, Harmony will assess the safety and efficacy of pitolisant in treating EDS and behavioral disturbances in PWS, anticipated to begin in Q1.
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