Arrowhead's Plozasiran Gains FDA STAR Program Entry for Severe Hypertriglyceridemia
Event summary
- FDA granted Arrowhead's plozasiran entry into the STAR pilot program for severe hypertriglyceridemia (sHTG).
- The STAR program accelerates review timelines, potentially cutting approval time to 6 months with expedited review options.
- Arrowhead retains its Priority Review Voucher (PRV) purchased in August 2026 for future use or monetization.
- The company plans to submit a supplemental new drug application (sNDA) for plozasiran in sHTG by year-end 2026.
The big picture
Arrowhead's inclusion in the FDA STAR program underscores the agency's push to expedite approvals for therapies addressing severe hypertriglyceridemia, a condition with limited treatment options. The strategic retention of the PRV provides Arrowhead with financial and operational flexibility, potentially enhancing its valuation and competitive positioning in the rare disease space. This move aligns with broader industry trends toward accelerated regulatory pathways for therapies with substantial clinical benefits.
What we're watching
- Regulatory Efficiency
- How the FDA STAR program's expedited review will impact Arrowhead's timeline for plozasiran approval in sHTG.
- Strategic Flexibility
- Whether Arrowhead will monetize or redeploy its retained Priority Review Voucher for future applications.
- Market Expansion
- The pace at which Arrowhead can secure regulatory approvals in additional global markets beyond the U.S., EU, China, Australia, and Canada.
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