Sulbactam-Durlobactam Granted Priority Review With China’s Medical Regulatory Body

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted sulbactam-durlobactam (SUL-DUR) a priority review status for a New Drug Application (NDA) for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains.

SUL-DUR is an intravenous investigational drug developed by Entasis Therapeutics. The therapy is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV β-lactamase inhibitor, or BLI, being developed for the treatment of infections caused by ABC, including multidrug and carbapenem-resistant strains.

Entasis granted Zai Lab Zai Lab an exclusive license to develop and commercialize SUL-DUR in Greater China (mainland China, Hong Kong, Taiwan and Macau), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan.

“The CDE’s decision to grant priority review to our NDA for SUL-DUR underscores the importance of addressing the urgent need for new treatment options for patients with life-threatening infections caused by Acinetobacter species including multidrug and carbapenem-resistant strains,” Harald Reinhart, MD, president and head of Global Development, Neuroscience, Autoimmune and Infectious Diseases, Zai Lab, said in a statement. “CRAB infections are among the worst bacterial infections, and safe and effective treatment options are limited. We thank the agency for their commitment and continued support to patients in need and look forward to working closely with them to advance this important therapy toward approval in China, where CRAB infections are still frequently seen in ICUs and result in high mortality rates.”

No specific date has been offered in the NDA information. SUL-DUR has been designated a Qualified Infectious Disease Product by the US FDA, a designation that aims to spur development of new antibiotics for difficult-to-treat infections. The FDA has accepted the SUL-DUR NDA for priority review with an action date of May 29, 2023.