High unmet need for a deadly infection helped secure Entasis Therapeutics Holdings Inc.’s antibiotic an easy approval recommendation from US Food and Drug Administration advisors despite a single, small Phase III study and several concerns the panel wants FDA and the company to address post-market.
The Antimicrobial Drugs Advisory Committee voted 12-0 on 17 April that the overall benefit-risk assessment is favorable for the use of sulbactam-durlobactam (SUL-DUR) for the treatment of patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)