Imposing Everolimus REMS On Sirolimus Rests On If There Is New Safety Info
This article was originally published in Pharmaceutical Approvals Monthly
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.