FDA accepts Merck & Co’s two new antibacterial drug applications
Pharmaphorum Media Limited | February 06, 2019
The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first application is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria. In addition, the FDA has accepted a supplemental filing for Zerbaxa (ceftolozane and tazobactam) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative microorganisms.
In the US, 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. US-based Merck & Co, known as MSD outside the US and Canada, had previously announced its intention to file for this new indication for the drug after positive results from the phase III ASPECT-NP trial, testing the drug in ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).