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Alexion’s Soliris REMS Working Well But Might Benefit From Small Changes

 
• By Sue Sutter

FDA advisory committee will weigh potential tweaks to orphan drug’s risk management plan, which is meeting informational goals regarding meningococcal infections but could be burdening prescribers with repeated assessments.

Minor tweaks may be all the adjustments needed to the Risk Evaluation and Mitigation Strategy for Alexion Pharmaceuticals Inc.’s Soliris (eculizumab), according to briefing documents released ahead of the FDA Drug Safety and Risk Management Advisory Committee’s Nov. 18 meeting.

FDA and Alexion said the current REMS with elements to assure safe use (ETASU) appears to be meeting its goals of reducing the occurrence and morbidity of meningococcal infections and informing health care providers and patients about this serious risk

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