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?
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FDA’s annual REMS reviews haven’t been the most dramatic advisory committees in recent years. The latest review is the first to involve a major commercial product – Alexion’s Soliris – but also looked at a program that appears successful and non-controversial.
The U.K.s NICE is on the verge of recommending Alexion's Soliris for aHUS despite an astronomic price; but its request for R&D cost data will alarm the drug industry.
Cleveland Clinic hematologist suggests eculizumab risk management plan provides Alexion with an opportunity for direct-to-consumer marketing.