By Stephen Nakrosis


Innoviva, Inc. on Wednesday said the Food and Drug Administration accepted for priority review the new drug application for SUL-DUR, as a treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex, or ABC, including multidrug resistant and carbapenem-resistant strains.

David Altarac, chief medical officer of Entasis Therapeutics, a wholly-owned subsidiary of Innoviva, said "Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options."

Innoviva said the FDA is currently planning to hold an advisory committee meeting to discuss the application, and added the PDUFA date, which marks the end of the review period, is May 29, 2023.


Write to Stephen Nakrosis at stephen.nakrosis@wsj.com


(END) Dow Jones Newswires

11-30-22 1726ET