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 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 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.