Arrowhead says FDA grants plozasiran entry into STAR pilot program for severe hypertriglyceridemia sNDA
ARWR•The FDA granted plozasiran entry into the STAR pilot program for an sNDA in severe hypertriglyceridemia. Arrowhead targets a year-end 2026 submission, which the company says could qualify for a six-month Priority Review and an action at least one month earlier, while keeping its Priority Review Voucher for another use or monetization.
1. FDA pilot acceptance
The FDA granted plozasiran entry into the STAR pilot program for an sNDA in severe hypertriglyceridemia. Arrowhead targets submitting the sNDA by year-end 2026.
2. Review timeline and voucher
STAR acceptance positions the filing for a six-month Priority Review, with a potential action at least one month earlier. Arrowhead plans to keep its Priority Review Voucher for another use or monetization.
