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FDA’s Decision To Back Off Korlym REMS Shows Context Is King

Corcept’s NDA for the controversial agent mifepristone in Cushing’s syndrome required that FDA balance the needs of prospective patients with a severe orphan disease with the desire to preserve the drug’s REMS for abortifacient use as Mifeprex. FDA’s decision to forgo a REMS was grounded on principle, precedent, and assessment of real-world likelihood of off-label use – and vetted all the way to the CDER director.

FDA’s approval of Corcept Therapeutics Inc.’s Korlym for Cushing’s disease without a Risk Evaluation and Mitigation Strategy shows how the agency put practical considerations and precedent above potential political implications – but not without taking the decision all the way to Center for Drug Evaluation and Research Director Janet Woodcock for vetting.

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