By IDSE News Staff
The FDA granted a new indication for imipenem-cilastatin-relebactam (IMI/REL) (Recarbrio, Merck) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by certain susceptible gram-negative microorganisms.
The new FDA approval was based on the RESTORE-IMI 2 trial, a phase 3, multinational, randomized, double-blind, noninferiority study evaluating the efficacy and safety of IMI/REL compared with