FDA Approves Merck’s Recarbio for Hospital-Acquired Pneumonia

The FDA has approved Merck’s Recarbio (imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients ages 18 years and older.

The approval was based on the results of a phase 3 clinical trial, in which Recarbio demonstrated noninferiority to piperacillin-tazobactam in 28-day mortality and clinical response at early follow-up.

Recarbio was previously approved for treatment of complicated urinary tract infections and complicated intra-abdominal infections in patients with limited or no alternative treatment options.