PolarityBio's SkinTE BLA Accepted for Priority Review in Diabetic Foot Ulcers
核心洞察
PolarityBio (搜索) said the FDA has accepted for filing its Biologics License Application for SkinTE in Wagner Grade 1 diabetic foot ulcers (搜索) under priority review.
The filing sets a PDUFA target action date, and the company is advancing market access and commercial readiness activities ahead of a potential approval.
The BLA is supported by the COVER DFUS II pivotal Phase III trial, which randomized 120 patients 1:1 to SkinTE plus standard of care or standard of care alone.
PolarityBio (搜索) announced that the FDA has accepted for filing its Biologics License Application for SkinTE, a first-in-class autologous cutaneous multicellular therapy, for the treatment of Wagner Grade 1 diabetic foot ulcers (搜索). The application was granted priority review, and a PDUFA target action date is now established. SkinTE remains investigational and has not been approved by the FDA for any indication. The program holds Regenerative Medicine Advanced Therapy and Breakthrough Therapy designations.
The filing is supported by COVER DFUS II (NCT06140303), a pivotal Phase III multicenter randomized controlled trial that enrolled 120 patients across multiple U.S. sites over 14 months. Participants were randomized 1:1 to SkinTE with standard of care or standard of care alone and followed for 24 weeks. The primary efficacy endpoint was the incidence of complete wound closure within 12 weeks; eligible patients had a diabetic foot ulcer persisting at least four weeks despite prior treatment and completed a two-week run-in with rigorous standard of care.
PolarityBio (搜索), based in Salt Lake City, Utah, is developing regenerative multicellular biologics and is also advancing SkinTE for venous leg ulcers (搜索) and pressure injuries (搜索). SkinTE is currently available for investigational use only through an Expanded Access Program. The company noted that under current Centers for Medicare & Medicaid Services policy, wound therapies regulated under a BLA continue to receive separate payment as biological products under established Medicare Part B methodologies, following Medicare payment changes that took effect on January 1, 2026.