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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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