FDA bats down Merck's sugammadex in third rejection

Merck execs used their quarterly review today to confirm that the troubled drug Bridion (sugammadex) has once again been rejected at the FDA. This is the drug's third stiff arm at the agency, which comes after R&D chief Roger Perlmutter had vowed that the pharma giant was finally back on track. Bridion, though, has proven to be too attractive to give up on and too alarming to be approved. The therapy is designed to reverse the effects of anesthesia in surgery, but regulators have never been able to be satisfied by the safety data concerning hypersensitivity. The long-stymied development program for this drug has become an enduring embarrassment for Merck ($MRK), which has sought to distance itself from a long track record of setbacks in the clinic. The FDA's first rejection came 7 years ago. Report

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