The U.S. Food and Drug Administration approved Merck & Co. Inc.’s combination antibiotic Recarbrio for the expanded indication in the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
The drug had received initial approval in the U.S. in July 2019 to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.
Recarbrio is a combination of Imipenem, a penem antibacterial, Cilastatin, a renal dehydropeptidase inhibitor, and Relebactam, a betalactamase inhibitor. The drug is administered intravenously by a health care professional.
Hospital-acquired bacterial pneumonia or HABP and ventilator-associated bacterial pneumonia or VABP are a type of pneumonia that occurs in hospitalized patients with symptoms including fever, chills, cough, chest pain and increased oxygen requirements.
The company evaluated the safety and efficacy of Recarbrio for the treatment of HABP/VABP in a randomized, controlled clinical trial of 535 hospitalized adults.
The FDA granted Fast Track and Priority Review designations for this application.
The agency in February this year had accepted for review a supplemental new drug application or sNDA for Recarbrio to treat HABP/VABP patients. Further, in May, Merck announced positive results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating Recarbrio in patients with HABP/VABP.
The FDA Prescription Drug User Fee Act or PDUFA goal date was Wednesday, June 4.
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