Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea...

{
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  "signal_type": "news",
  "signal_subtype": "launches",
  "detected_at": "2026-09-16T10:59:00+00:00",
  "company": {
    "name": "Viatris",
    "domain": "viatris.com"
  },
  "data": {
    "url": "https://www.prnewswire.com/news-releases/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-302880472.html",
    "title": "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",
    "excerpt": "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 ® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction, and approval for narcolepsy (type 1 and 2 – with and without cataplexy). WAKIX is the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications. \"As Japan's first approved histamine H3 receptor antagonist/inverse agonist for these conditions, WAKIX offers a much-needed novel treatment option for patients,\" said Philippe Martin , Viatris Chief R&D Officer. \"This milestone marks an important advancement for sleep medicine in Japan and brings forward a treatment option that is not classified as a controlled substance. We continue to strengthen Viatris' innovative medicines portfolio in this strategically important market by investing in differentiated therapies for patients.\" EDS is a shared and clinically significant symptom of both OSAS and narcolepsy and remains an area of unmet medical need in Japan. In patients with OSAS, EDS can adversely affect daily...",
    "product": "WAKIX",
    "summary": "Viatris announced that its drug WAKIX® (pitolisant) has received approval from Japan's Ministry of Health, Labour and Welfare for treating excessive daytime sleepiness associated with obstructive sleep apnea syndrome and for narcolepsy.",
    "location": "Japan",
    "planning": false,
    "image_url": "https://mmx.prnewswire.com/media/MS627787/Viatris-OUS-Logo.jpg?id=OA2950824&p=facebook",
    "confidence": 1,
    "product_data": {
      "name": "WAKIX",
      "full_text": "WAKIX ® (pitolisant)",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical",
      "general_technology"
    ],
    "published_at": "2026-09-16T10:59:00Z",
    "location_data": [
      {
        "region": "Eastern Asia",
        "country": "Japan",
        "continent": "Asia",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-09-16",
    "article_sentence": "(Nasdaq: VTRS ), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for WAKIX ® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction, and approval for narcolepsy (type 1 and 2 – with and without cataplexy)."
  }
}

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