Recarbrio sNDA accepted for FDA priority review

The US Food and Drug Administration 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, submitted by pharma giant Merck & Co (NYSE: MRK), has received Priority Review by the FDA, and the Prescription Drug User Fee Act (PDUFA) date for the sNDA is June 4, 2020.

Modest sales forecast