Posted by Michael Wonder on 04 Feb 2020
FDA accepts for review supplemental new drug application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia
3 February 2020 - Filing receives priority review.
Merck today announced that the U.S. FDA has accepted for review a supplemental new drug application 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 application is 4 June 2020.
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.
