US FDA panel backs Innoviva's drug for multidrug-resistant bacterial infections (updated)

Innoviva

17/04/2023 21:57

(Adds details and background)
       April 17 (Reuters) - A panel of U.S. Food and Drug
Administration advisers on Monday unanimously voted in favor of
Innoviva Inc's  INVA.O   experimental antibiotic in the
treatment of serious bacterial infections, typically associated
with hospitalizations, the company said.
    Innoviva is seeking the U.S. health regulator's nod for the
drug, sulbactam-durlobactam, as a treatment for
hospital‐acquired and ventilator‐associated bacterial pneumonia
caused by susceptible strains of the bacteria called
acinetobacter baumannii-calcoaceticus complex.
    The FDA panel voted 12-0 in favor of the drug as a potential
treatment for serious infections caused by the bacteria,
including multidrug-resistant strains.    
    Entasis Therapeutics, which was acquired by Innoviva last
year, is developing the drug, its lead asset, in partnership
with Zai Lab Ltd  9688.HK .
    The health regulator, which usually follows the
recommendations of its expert panel but is not obligated to do
so, is expected to make its final decision by May 29 on the use
of the drug.
    

 (Reporting by Sriparna Roy and Raghav Mahobe in Bengaluru;
Editing by Krishna Chandra Eluri)
 ((Sriparna.Roy@thomsonreuters.com;))