When To End A REMS? Soliris Review Stirs Debate On How To Scale Back

Risk management program for Alexion’s orphan drug eculizumab appears to be succeeding, but what does FDA need to see to make it less burdensome?

More than seven years after FDA was empowered to require Risk Evaluation and Mitigation Strategies to ensure that drugs’ benefits outweigh their risks, the agency is still struggling to figure out how much evidence is needed to scale back a REMS.

The apparent success of the REMS for Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) shows the challenges FDA faces in determining...

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