PETACH TIKVA, ISRAEL
PolyPid's D-PLEX100 NDA accepted with Priority Review for surgical site infection prevention
- Sponsor
- PolyPid $PYPD
- Drug
- D-PLEX100
- Indication
- prevention of surgical site infection in abdominal colorectal surgery
FDA accepted PolyPid's New Drug Application for D-PLEX100 with Priority Review designation. D-PLEX100 is a locally delivered biodegradable polymer-lipid matrix that releases doxycycline directly at the surgical site over a controlled multi-week window, intended to prevent surgical site infections in abdominal colorectal surgery. Priority Review shortens the review clock to six months from the standard ten.
What this means
D-PLEX100 is a drug-eluting implant placed during surgery to release antibiotics directly at the surgical site over time. Today the FDA accepted PolyPid's application for priority review, setting a faster decision timeline. If approved, it could offer a new method to prevent infections after abdominal colorectal surgery.