Zerbaxa filed with FDA and given priority review for nosocomial pneumonia.- Merck Inc

Merck Inc announced that the FDA has accepted for review a regulatory filing for Priority Review for Zerbaxa (ceftolozane and tazobactam) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative microorganisms. The Prescription Drug User Fee Act (PDUFA) target action date is June 3, 2019. In the U.S., Zerbaxa is currently indicated for the treatment of adult patients with cUTI, including pyelonephritis, caused by certain susceptible Gram-negative microorganisms, and is also indicated, in combination with metronidazole, for the treatment of adult patients with cIAI caused by certain susceptible Gram-negative and Gram-positive microorganisms.

The Zerbaxa sNDA is based on the pivotal Phase III ASPECT-NP trial in adults with ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia. Merck plans to present results from the ASPECT-NP study at a future scientific conference.