Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee

Apr 17, 2023

Innoviva, Inc. (Nasdaq: INVA) (Innoviva), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in support of approval based on a favorable benefit-risk assessment of sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The sulbactam-durlobactam New Drug Application (NDA), filed by Entasis Therapeutics Inc., a wholly owned subsidiary of Innoviva, was accepted and granted Priority Review by the FDA in November 2022, with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.

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