A new BMJ investigation and companion editorial published earlier this week is raising questions on if the FDA lowered its standards to approve Merck’s antibiotic Recarbrio (imipenem/cilastatin/relebactam) in 2019 to treat complicated intra-abdominal and complicated urinary tract infections (cIAI and cUTI) for patients who have few or no other treatment options.
FDA has approved Merck’s Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial (HABP/VABP) pneumonia in patients aged 18 years or older.
The US Food and Drug Administration (FDA) approved Recarbrio (a combination of 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.
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. See Selected Safety Information below.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), the active comparator, in the primary and key secondary endpoints of the study, 28-day all-cause mortality and clinical response, respectively. In February 2020, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for use of RECARBRIO in this patient population. The FDA Prescription Drug User Fee Act (PDUFA) goal date is June 4, 2020. Phase 3 trial data are now available in a compendium of presentations posted by Merck, coinciding with publication of study abstracts by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), the active comparator, in the primary and key secondary endpoints of the study, 28-day all-cause mortality and clinical response, respectively. In February 2020, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for use of RECARBRIO in this patient population. The FDA Prescription Drug User Fee Act (PDUFA) goal date is June 4, 2020. Phase 3 trial data are now available in a compendium of presentations posted by Merck, coinciding with publication of study abstracts by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting.