CHMP recommends updated indications for Soliris in PNH-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, in the treatment of paroxysmal nocturnal haemoglobinuria for patients with high disease activity regardless of history of transfusion.
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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