FDA grants approval of Recarbrio (imipenem, cilastatin, and relebactam) for treatment of hospital-acquired or ventilator-associated bacterial pneumonia

Approval was based on the RESTORE-IM 2 RCT which demonstrated non-inferiority in 28 day all-cause mortality vs piperacillin-tazobactam (n=535; 15.9% vs 21.3%). Relebactam is a beta-lactamase inhibitor that is designed to restore susceptibility to imipenem in resistant strains.

SPS commentary:

 In the EU, Recarbrio has been granted approval for gram-negative infections, but should be reserved for use in patients with limited treatment options.


US Food and Drug Administration