After a complete response letter (CRL) for the cataplexy indication was issued by the FDA in August 2019, Harmony met with the Agency in December 2019 to discuss the deficiencies cited in the CRL. WAKIX is administered orally, once daily in the morning upon wakening.įDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. WAKIX, a first-in-class medication, is a selective histamine 3 (H ₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. He is also the co-founder, with Jeanne-Marie Lecomte, of Bioprojet. Professor Schwartz is the discoverer of histaminergic neurotransmission in the brain and the histamine-3 receptor, which is the target receptor of WAKIX. This approval highlights the recognition by the FDA of a new therapeutic option in the treatment of the two major symptoms of narcolepsy by a drug with a novel mechanism of action," said Professor Jean-Charles Schwartz, PhD. "From the very beginning, our passion at Bioprojet has been to bring WAKIX to people living with the daily challenges that are associated with impaired wakefulness and the risk of cataplexy attacks. "At Harmony, we always keep patients at the heart of all we do and with this approval, we are inspired to continue our mission to develop novel treatment options for those living with rare, neurological disorders who have unmet medical needs." ![]() Jacobs, Harmony’s President and Chief Executive Officer. "This approval underscores our ongoing commitment to support people who are living with narcolepsy," said John C. "Today’s FDA approval of the cataplexy indication for WAKIX, coupled with it being the first and only non-scheduled treatment option approved for adult patients with narcolepsy to treat both excessive daytime sleepiness or cataplexy, provides an opportunity for WAKIX to offer broad clinical utility to healthcare professionals managing adult patients living with narcolepsy." ![]() "All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Food and Drug Administration (FDA) has approved WAKIX ® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. ![]() ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, PA and CHICAGO, IL, OctoHarmony Biosciences Holdings, Inc. WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
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