{
  "id": 3246312,
  "title": "BioCryst gets Japan approval for HAE drug in young children",
  "url": "https://urgent.news/2026/08/25/biocryst-gets-japan-approval-for-hae-drug-in-young-children",
  "topic": "finance",
  "section": "Finance & Markets",
  "published": "2026-08-25T11:12:38.000Z",
  "source": {
    "name": "Investing.com",
    "slug": "investing-com",
    "url": "https://www.investing.com/news/company-news/biocryst-gets-japan-approval-for-hae-drug-in-young-children-93CH-4875079"
  },
  "original_language": "en",
  "account": null,
  "summary": "BioCryst Pharmaceuticals Inc. has announced that Japan's Ministry of Health, Labor and Welfare has approved ORLADEYO (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema aged 2 to under 12 years. The drug, which is administered as a granule formulation, was approved based on interim results from the APeX-P clinical trial. ORLADEYO demonstrated a consistent safety profile across this age group, with the most commonly reported adverse event being nasopharyngitis. The approval follows the FDA's approval of the capsule formulation for adult and pediatric patients 12 years and older in December 2020, and the oral pellet formulation's approval for U.S. pediatric patients in December 2025. BioCryst will launch ORLADEYO for children in Japan following completion of the Japanese National Health Insurance System reimbursement pricing process.",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}