Alexion’s Soliris REMS Gets FDA Panel Review In Wider Evaluation Effort
This article was originally published in The Pink Sheet Daily
FDA advisory committee will revisit REMS for ultra-rare disease drug as part of larger agency effort to evaluate the effectiveness of the safety programs.
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FDA chose to focus on communication instead of use restrictions to manage PML risk with Takeda’s Entyvio after looking long and hard at REMS options and the potential unintended effects of the risk management plans on drug utilization.
NICE is undeniably impressed with Alexion’s Soliris for treating aHUS but wants more data to justify its eye-watering price tag.
“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.