Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase III clinical trial of D-Plex.
PolyPid Ltd announced today that the Company’s lead product candidate, D-Plex (doxycycline/polymer-lipid encapsulation matrix), a secured antibiotic drug reservoir that provides a safe and effective local anti-bacterial prevention and treatment measure during surgical procedures, has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. FDA.
Under the FDA’s QIDP program, which is designed to speed the development of novel drugs against important pathogens, PolyPid will be able to take advantage of certain incentives, including FDA priority review, eligibility for fast-track status and an additional five-years of market exclusivity when marketing approval is granted for D-Plex in preventing post-cardiac surgery sternal infection.
