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.
Enforcement Report - Week of February 22, 2023
Merck aims to mothball production at the facility in Danville, Pennsylvania, sometime in 2024, the company told Fierce Pharma in an emailed statement. The facility manufactures nonsterile imipenem and cilastatin for the antibiotics Primaxin/Tienam and Recarbrio, plus ertapenem sodium for Invanz, a Merck spokesperson said.
MSD’s novel antibiotic treatment Recarbrio has launched in the UK as concerns grow over the rise of antimicrobial resistance (AMR) globally.
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.
Merck's antibiotic Recarbrio won its first FDA nod in July. Now, thanks to new trial results in severe pneumonia, it's eyeing another approval.
According to an anonymous source who reported to Reuters, French drugmaker Sanofi plans to ax 200 jobs in Japan across sales, regulatory affairs and operations. This adds to the ongoing plans of reorganization by research chief John Reed. Back in June, the company announced it would be placing 466 jobs in France and Germany on the chopping block and trimming of their staff in the US by offering employees an “early exit”. A Sanofi representative added, “Sanofi Japan plans to implement a voluntary retirement programme in order to adapt to the external environment changes and to transform our business models to continue our growth.”