PolyPid Gains $4.3M PDUFA Fee Waiver, On Track for D-PLEX100 NDA
FDA granted PolyPid a $4.3 million small business waiver for the PDUFA fee on its D-PLEX100 NDA, freeing resources for commercialization and on track with rolling submission this month. D-PLEX100's Phase 3 SHIELD II trial showed a 60% (p=0.0013) reduction in surgical site infections in abdominal colorectal surgeries.
1. FDA Grants PDUFA Fee Waiver
PolyPid received a $4.3 million small business waiver for the Prescription Drug User Fee Act fee on its NDA for D-PLEX100. This waiver allows reallocation of funds toward regulatory filings and commercialization preparations.
2. Phase 3 SHIELD II Trial Outcomes
In the SHIELD II trial, D-PLEX100 achieved a statistically significant 60% relative risk reduction (p=0.0013) in surgical site infections following abdominal colorectal surgery, meeting its primary and all key secondary endpoints.
3. Rolling NDA Submission and Commercial Strategy
PolyPid expects to initiate its rolling NDA submission for D-PLEX100 by the end of the month, following positive FDA pre-NDA feedback, and is engaged in advanced commercial partnership discussions for the U.S. market.