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Alexion’s Soliris REMS Gets FDA Panel Review In Wider Evaluation Effort

 
• By Lisa LaMotta

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.

FDA’s latest REMS under a microscope is the program for Alexion Pharmaceuticals Inc.’s Soliris. But the rare disease blockbuster’s Risk Evaluation and Mitigation Strategy isn’t coming in for an overhaul, but rather a check up as part of the agency’s broader efforts to ensure that REMS are not an undue burden on the healthcare system.

FDA announced Oct. 2 that it will host a meeting of the Drug Safety and Risk Management advisory committee (DSaRM)...

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