Arrowhead Pharmaceuticals Granted Entry in the FDA STAR Pilot Program for Plozasiran in Severe Hypertriglyceridemia
Business Wire•07/10/2026•07:30 ET
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Key Highlights
- ➤FDA grants plozasiran entry into STAR pilot for severe hypertriglyceridemia
- ➤STAR eligibility provides six-month Priority Review versus 10-month standard review
- ➤Arrowhead targets sNDA submission for severe hypertriglyceridemia by year-end 2026
- ➤Arrowhead retains previously purchased Priority Review Voucher for future use or monetization
- ➤REDEMPLO is approved across the U.S., EU, China, Australia, and Canada for FCS
Expert Statements
Christopher Anzalone, President and CEO of Arrowhead Pharmaceuticals
“We are committed to pursuing every potential opportunity to accelerate the process of bringing plozasiran to patients, and the FDA STAR Pilot program provides important benefits to sponsors with efficacy supplements”
Christopher Anzalone, President and CEO of Arrowhead Pharmaceuticals
“In addition, earning Priority Review for plozasiran without the need to use a PRV gives us the option to redeploy our voucher for a future application or monetize it.”
Arrowhead Pharmaceuticals Granted Entry in the FDA STAR Pilot Program for Plozasiran in Severe Hypertriglyceridemia
- FDA STAR pilot program aims to shorten the time from complete supplement submission to the action date to allow earlier patient access to therapies that address an unmet medical need
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