Arrowhead Gets FDA Breakthrough Therapy Designation for Severe Hypertriglyceridemia Drug

Dow Jones

2025/12/02

By Nicholas G. Miller

The Food and Drug Administration granted breakthrough therapy designation to Arrowhead Pharmaceuticals' plozasiran drug to treat severe hypertriglyceridemia.

The designation expedites the development and review of drugs for which preliminary evidence indicates substantial improvement over available therapies to treat serious conditions.

Arrowhead intends to complete phase three clinical trials of the drug in the middle of next year and submit a supplemental new drug application by the end of 2026.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

December 02, 2025 07:55 ET (12:55 GMT)

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Miller \n\n\n \n\n\n  The Food and Drug Administration granted breakthrough therapy designation to Arrowhead Pharmaceuticals' plozasiran drug to treat severe hypertriglyceridemia. \n\n\n  The designation expedites the development and review of drugs for which preliminary evidence indicates substantial improvement over available therapies to treat serious conditions. \n\n\n  Arrowhead intends to complete phase three clinical trials of the drug in the middle of next year and submit a supplemental new drug application by the end of 2026. \n\n\n \n\n\n  Write to Nicholas G. Miller at nicholas.miller@wsj.com. \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 02, 2025 07:55 ET (12:55 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}