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

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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