Imposing Everolimus REMS On Sirolimus Rests On If There Is New Safety Info
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The approval of Novartis' Zortress (everolimus) with a Risk Evaluation and Mitigation Strategy has opened up an FDA review of whether Pfizer's Rapamune (sirolimus), from which everolimus is derived, should have a similar plan
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Sponsors cannot cut corners in developing clinical data to support a revised dosing scheme, even when a drug’s efficacy has already been shown, Novartis learned while shepherding its kidney transplant agent Zortress (everolimus) through the FDA approval process.