Arrowhead’s plozasiran accepted into FDA STAR program for severe hypertriglyceridemia
Arrowhead Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted its supplemental new drug application for plozasiran into the Split Real‑Time Application Review (STAR) pilot program. The program provides a six‑month priority review for the severe hypertriglyceridemia indication. Arrowhead must file the sNDA by the end of 2026. The drug is already approved for a related rare triglyceride disorder.
Why it matters
The company says the STAR entry will accelerate regulatory review, potentially bringing the product to market sooner and allowing it to keep its priority‑review voucher for future use. Faster approval could improve revenue prospects if the indication is approved.
Key facts
- 1The FDA accepted plozasiran into the STAR pilot program for its severe hypertriglyceridemia supplemental new drug application. tradingview.com
- 2Arrowhead must submit the supplemental new drug application by year‑end 2026. tradingview.com
- 3The STAR program shortens the review period to six months compared with the standard ten‑month review. investing.com
- 4Plozasiran is already approved in the United States, European Union, China, Australia, and Canada for a related condition (familial chylomicronemia syndrome). investing.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.