Merck gets FDA priority review for Recarbrio in HABP/VABP

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO (imipenem, cilastatin, and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. The application has received Priority Review by the FDA, and the Prescription Drug User Fee Act (PDUFA) date for the sNDA is June 4, 2020.

“This submission reinforces Merck’s continued dedication to researching and developing potential antibiotic treatment options which address unmet medical needs,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “We are unwavering in our commitment to evaluate treatments for infections caused by certain Gram-negative pathogens.”

The submission is based on the results of the pivotal Phase 3 RESTORE-IMI 2 trial in adult patients with HABP/VABP. The full data has been accepted for presentation at the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2020), which will take place in Paris, France, April 18 – 21, 2020.

RECARBRIO was initially approved by the FDA in July 2019 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, in adults who have limited or no alternative treatment options.