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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.

The active ingredient in Korlym, mifepristone, also is approved as an abortifacient as Danco Laboratories’ Mifeprex, and as such is subject to a REMS. FDA review documents reveal that early...

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