CHMP recommends updating indication for Soliris in aHUS-Alexion
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to update the therapeutic indication for Soliris (eculizumab), from Alexion, with additional data on the benefits of long-term treatment and the risks associated with treatment discontinuation in patients with atypical haemolytic uremic syndrome (aHUS).
The CHMP based its opinion on efficacy and safety data from an observational, non-interventional international PNH Registry, which confirmed that patients with no history of transfusion who were treated with Soliris had a significant reduction in haemolysis (measured by LDH) and associated clinical symptoms, such as fatigue.
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