FDA's AdComm Panel Favors Innoviva's Drug For Multidrug-Resistant Bacterial Infections

• The FDA's Antimicrobial Drugs Advisory Committee unanimously voted 12-0 in support of approval of Innoviva Inc's (NASDAQ: INVA) sulbactam-durlobactam for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

• The sulbactam-durlobactam marketing application was accepted and granted Priority Review by the FDA in November 2022, with a PDUFA target action date of May 29, 2023.

• Entasis Therapeutics, acquired by Innoviva last year, is developing the drug in partnership with Zai Lab Ltd (NASDAQ: ZLAB).

• Also Read: Innoviva Bolsters Its Infectious Disease, Hospital Portfolio With La Jolla Deal.

• The Committee based its recommendation on the totality of scientific evidence, including results from the landmark Phase 3 trial.

• In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality and a significant difference in clinical cure rates.

• Sulbactam-durlobactam also exhibited a favorable safety profile with a statistically significant lower incidence of nephrotoxicity.

• If approved, the company will "look to explore commercial availability sometime later in the year," David Altarac, chief medical officer of Entasis Therapeutics, told Reuters ahead of the panel meeting.

• Price Action: INVA shares are down 1.13% at $13.07 during the premarket session on the last check Tuesday.

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