Ionis Pharmaceuticals Wins CHMP Backing for DAWNZERA in Hereditary Angioedema Prevention

Reuters

2025/11/14

Ionis Pharmaceuticals Wins CHMP Backing for DAWNZERA in Hereditary Angioedema Prevention

Ionis Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency has issued a positive opinion recommending approval of DAWNZERA™ (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema $(HAE)$ in adults and adolescents aged 12 years and older. The recommendation is based on robust clinical evidence from the Phase 3 OASIS-HAE and OASISplus studies, which demonstrated significant reductions in HAE attack rates. The final approval decision now rests with the European Commission, with a decision expected in the first quarter of 2026. Otsuka Pharmaceutical Co., Ltd. holds exclusive rights to bring donidalorsen to patients in Europe and Asia Pacific.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ionis Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251113183682) on November 14, 2025, and is solely responsible for the information contained therein.

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ID: 20251113183682) on November 14, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IONS","symbol_name":"Ionis Pharmaceuticals, Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251114:nNDL950lV3:1","article_id":"2583250878","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2583250878","pubTimestamp":1763121634,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Ionis Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency has issued a positive opinion recommending approval of DAWNZERA  for the routine prevention of recurrent attacks of hereditary angioedema  in adults and adolescents aged 12 years and older. 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