Merck defends antibiotic's approval from 2019 as BMJ investigation points to 'decline' in FDA standards

17 May 2023
endpts.com
Drug ApprovalQualified Infectious Disease Product
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. The BMJ article raises questions cited in the FDA’s review memorandum, released as part of Recarbrio’s approval, which noted that the agency generally accepts 10% worse efficacy for non-inferiority studies in cUTI. However, Merck chose a 15% worse efficacy cut-off and didn’t hit that target, meaning it would allow “as many as one in seven patients to potentially have a worse outcome and still declare the trial a success.”
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