INVA - Innoviva Entasis' bacterial pneumonia drug Xacduro wins FDA approval

2023-05-24 06:03:52 ET

• Innoviva ( NASDAQ: INVA ) said the the U.S. Food and Drug Administration (FDA) approved bacterial pneumonia therapy Xacduro.
• The new drug application (NDA) for Xacduro (sulbactam for injection; durlobactam for injection) was filed by Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics, a unit of Innoviva unit.
• Innoviva Specialty said the FDA approved Xacduro, co-packaged for intravenous use in patients 18 years of age and older to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
• "XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter," said David Altarac, chief medical officer, Innoviva Specialty.
• The approval was backed by data, including results from a phase 3 trial called ATTACK.
• In April, a panel of the FDA had unanimously voted in favor of approval of the drug.
• INVA -2.07% to $13.26 premarket May 24

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