Viatris: WAKIX (pitolisant) inaprubahan sa Japan para sa narcolepsy at OSAS-EDS

Ang Ministry of Health, Labour and Welfare ng Japan ang nagbigay ng marketing approval para sa WAKIX (pitolisant) para sa narcolepsy (type 1 at 2) at excessive daytime sleepiness na may kaugnayan sa obstructive sleep apnea syndrome. Ang approval ay suportado ng domestic Phase 3 trials at international studies. Ang WAKIX ang naging unang histamine H3 receptor antagonist/inverse agonist na inaprubahan sa Japan para sa mga indikasyong ito.

Mahahalagang fact

Na-file: Set 16, 2026, 06:59 PM
Kaganapan: Pag-apruba ng FDA
Direksyon: Positibo
Kumpanya: VTRSViatris
Asset: pitolisant GR
Pinagmulan: Press release ng kumpanya
Kumpiyansa: May source

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Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Syndrome Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Syndrome News provided by Viatris Inc. Sep 16, 2026, 06:59 ET Share this article Share to X Share this article Share to X Approval Addresses High Unmet Medical Need and Further Advances Viatris' Innovative Portfolio in Japan PITTSBURGH , Sept. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS ), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for WAKIX ® (p

Press release ng kumpanya