FDA mull Merck’s Recarbrio in bacterial pneumonia indication

Credit: Shutterstock.com/ Piotr Adamowicz

Merck’s supplemental New Drug Application (sNDA) for Recarbrio to treat adult patients with hospital acquired and ventilator-associated bacterial pneumonia (HABP/VABP) has been accepted for review by the FDA.

The submission is based on the results of the pivotal Phase 3 RESTORE-IMI 2 trial in adult patients with HABP/VABP.

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

This latest application has received Priority Review by the FDA, and the Prescription Drug User Fee Act (PDUFA) date for the sNDA is June 4, 2020.