Zai Lab and Pfizer Inc. are teaming up in China to fight the deadly carbapenem-resistant Acinetobacter baumannii (CRAB) infection with novel antibacterial drug Xacduro (sulbactam-durlobactam). Through the collaboration, Zai Lab will leverage Pfizer’s commercial infrastructure in the anti-infective space to widen access to Xacduro in mainland China. Terms of the deal were not released.
Zai Lab and Pfizer Inc. are teaming up in China to fight the deadly carbapenem-resistant Acinetobacter baumannii (CRAB) infection with novel antibacterial drug Xacduro (sulbactam-durlobactam). Through the collaboration, Zai Lab will leverage Pfizer’s commercial infrastructure in the anti-infective space to widen access to Xacduro in mainland China. Terms of the deal were not released.
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.
Despite concerns about a limited dataset to study, the urgent need to treat one of the toughest and most deadly infections propelled a U.S. FDA advisory committee to unanimously support the NDA for Entasis Therapeutics Inc.’s sulbactam-durlobactam (Sul-Dur). Sul-Dur, an injectable combination of beta-lactam antibiotic and beta-lactamase inhibitor for treating adults with hospital‐acquired bacterial pneumonia and ventilator‐associated bacterial pneumonia caused by susceptible strains of carbapenem-resistant Acinetobacter baumannii infections, has a May 29 PDUFA date.
With a May 29 PDUFA date nearing, the U.S. FDA’s Antimicrobial Drugs Advisory Committee meets April 17 to discuss the merits of Entasis Therapeutics Inc.’s hospital-acquired infection therapy.
Top-line results of a phase III trial testing sulbactam-durlobactam, a combination beta-lactam antibiotic and beta-lactamase inhibitor, in patients with carbapenem-resistant Acinetobacter baumannii infections, found the novel combo to be statistically noninferior to colistin in 28-day all-cause mortality, the study's primary endpoint.
