FDA grants Arrowhead's plozasiran entry into STAR pilot program

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration has granted plozasiran entry into the Split Real Time Application Review (STAR) pilot program, in connection with the company's planned supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG).

The FDA STAR pilot program is designed to shorten the time from a complete sNDA submission to the action date for certain supplemental indications of already-approved drugs. To qualify, the FDA must determine that clinical evidence from adequate and well-controlled investigations indicates the drug may demonstrate substantial improvement on a clinically relevant endpoint over available therapies.

Programs accepted into the STAR program receive a six-month Priority Review, compared to a standard 10-month review. The FDA may also target an action at least one month before the Priority Review goal date. Arrowhead said it will not need to use a Priority Review Voucher (PRV) it purchased in August 2026, retaining the option to redeploy or monetize it.

"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," said Christopher Anzalone, Ph.D., President and CEO of Arrowhead.

Arrowhead said it remains on schedule to submit the sNDA for plozasiran in sHTG by year-end 2026, with plans to seek approval from additional global regulatory authorities thereafter. Plozasiran is already approved in the U.S., the European Union, China, Australia, and Canada under the brand name REDEMPLO for adults with familial chylomicronemia syndrome, the most severe form of sHTG.

sHTG is characterized by triglyceride levels above 500 mg/dL and carries a significant risk of acute pancreatitis, which can require repeated hospitalizations and may be fatal. Sanofi holds rights to develop and commercialize REDEMPLO in Greater China, with Arrowhead retaining rights in all other geographies.

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