FDA Panel Backs Innoviva’s Drug for Multidrug-Resistant Bacterial Infections

(Reuters) – A panel of U.S. Food and Drug Administration advisers on Monday unanimously voted in favor of Innoviva Inc’s 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.

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.

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.

Sulbactam-durlobactam is an intravenous investigational drug, which showed a favorable safety profile and statistically significant reduction in nephrotoxicity, or damage caused to kidneys, in a late-stage trial when compared to a key last-line antibiotic therapy, colistin, in patients with infections caused by the bacteria.

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

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