Novo’s once-weekly Sogroya® (somapacitan) receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness)

{
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  "signal_type": "news",
  "signal_subtype": "is_developing",
  "detected_at": "2026-09-18T10:36:00+00:00",
  "company": {
    "name": "Novo Nordisk",
    "domain": "novonordisk.com"
  },
  "data": {
    "url": "https://www.globenewswire.com/news-release/2026/09/18/3364591/0/en/novo-s-once-weekly-sogroya-somapacitan-receives-positive-chmp-opinion-in-europe-for-children-with-idiopathic-short-stature-unexplained-shortness.html",
    "title": "Novo’s once-weekly Sogroya® (somapacitan) receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness)",
    "excerpt": "If approved, Sogroya® (somapacitan) would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, providing a much-needed treatment option for children and their families affected by this condition. Bagsværd, Denmark, 18 September 2026 – Novo Nordisk today welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending once-weekly Sogroya® for children with idiopathic short stature (ISS) with persistent growth disturbance. “Through our research and relationships with the community, we know that 70% of families raising children with ISS and other growth disorders feel unseen, and that the impact on their child's daily life simply isn't recognised,” said Ashley Gilmer, chief executive officer of International Coalition of Organizations Supporting Endocrine Patients (ICOSEP). “This recommendation is a meaningful signal that this may be starting to change. What matters now is that recognition turns into real support of timely diagnosis, clear information, and access to care for every family who needs it.” ISS affects up to 3% of children worldwide, yet it remains under-recognised and has limited options for managing its treatment 1,6-8 . As part of the REAL8 clinical trial, Sogroya® has been assessed for the treatment of ISS and acts as a long-acting growth...",
    "product": "Sogroya®",
    "summary": "Novo Nordisk's once-weekly growth hormone treatment, Sogroya® (somapacitan), received a positive opinion from the European Medicines Agency's CHMP, recommending it for children with idiopathic short stature.",
    "location": "Bagsværd, Denmark",
    "planning": false,
    "image_url": "https://ml-eu.globenewswire.com/Resource/Download/f87e6f85-3e50-4571-b9e5-8f683431f855",
    "confidence": 0.9,
    "product_data": {
      "name": "Sogroya",
      "full_text": "Sogroya® (somapacitan)",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical",
      "general_technology"
    ],
    "published_at": "2026-09-18T10:36:00Z",
    "location_data": [
      {
        "city": "Bagsværd",
        "state": "Capital Region of Denmark",
        "region": "Northern Europe",
        "country": "Denmark",
        "continent": "Europe",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-09-18",
    "article_sentence": "Novo Nordisk today welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending once-weekly Sogroya® for children with idiopathic short stature (ISS) with persistent growth disturbance."
  }
}

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