Innoviva Shares Halted as FDA Panel Reviews Sulbactam-Durlobactam

By Colin Kellaher

Trading in shares of Innoviva Inc. is halted on Monday ahead of a U.S. Food and Drug Administration advisory committee meeting to discuss the company's proposed treatment for a pair of healthcare-associated illnesses.

The FDA panel is slated to discuss whether the data contained in a new drug application filed by Innoviva's Entasis Therapeutics unit for sulbactam-durlobactam support its favorable benefit-risk assessment for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective.

The agency, which usually follows the advice of its advisory committees but it isn't bound by the recommendations, has set a target action date of May 29 for the application from Entasis, which is under priority review.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 17, 2023 09:40 ET (13:40 GMT)

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