Innoviva Specialty Therapeutics’ Xacduro Receives the US FDA’s Approval for Pneumonia Caused by Acinetobacter
Shots:
- The US FDA has approved Xacduro (IV) for hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia (HABP/VABP) caused by Acinetobacter in patients aged ≥18yrs.
- The approval was based on a P-III trial (ATTACK) evaluating Xacduro vs colistin which showed that Xacduro was found to be non-inferior over colistin for 1EPs of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter inf. with a significant difference in clinical cure rates
- The therapy was well tolerated & exhibited a favorable safety profile across the clinical program. Xacduro is supplied as a kit containing a single-dose vial of sulbactam 1g & 2 single-dose vials of durlobactam (0.5g in each vial) & is expected to be available in 2023
Ref: Businesswire | Image: Innoviva
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