By Chris Wack
NRx Pharmaceuticals has received qualified infectious disease product and fast-track designation from the U.S. Food and Drug Administration for NRX-101 in the treatment of complicated urinary tract infections and pyelonephritis.
Receipt of QIDP designation confers priority review, and five additional years of data-exclusivity to NRX-101's intellectual property position.
The FDA also granted NRX-101 fast-track designation for cUTI, which additionally allows for rolling submission of the company's New Drug Application.
NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
01-16-24 0710ET