FDA approves sNDA for Recarbrio

On Thursday, the US Food and Drug Administration approved a supplemental New Drug Application (sNDA) for Recarbrio (imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.

Merck & Co’s (NYSE: MRK) Recarbrio was approved by the FDA last July to treat patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) who have limited or no alternative treatment options.

The additional indication in HABP/VABP is based on results of the pivotal Phase III RESTORE-IMI 2 trial that compared Recarbrio 1.25 grams (imipenem 500mg/cilastatin 500mg/relebactam 250mg) to piperacillin/tazobactam 4.5 grams (PIP/TAZ, piperacillin 4,000mg/tazobactam 500mg), each administered intravenously every six hours for seven to 14 days, for the treatment of adult patients with HABP/VABP. Recarbrio met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively. The RESTORE-IMI 2 study abstract was published by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).