WASHINGTON (dpa-AFX) - Alexion (ALXN) Friday said the European Commission has approved updates to the EU label for the therapeutic indication of Soliris (eculizumab) in the treatment of paroxysmal nocturnal haemoglobinuria or PNH to now include patients without a history of transfusion.
With this approval, the revised Summary of Product Characteristics or SmPC now indicates that evidence of clinical benefit is demonstrated in patients with high disease activity as defined by elevated haemolysis and the presence of related clinical symptoms like fatigue, haemoglobinuria, abdominal pain, shortness of breath, anaemia, major adverse vascular event, dysphagia or erectile dysfunction.
This update further reinforces that transfusions do not impact the underlying disease process in PNH and that haemolysis plays the central role in disease activity, Alexion noted.
Additionally, the atypical haemolytic uraemic syndrome section of the EU label has been updated to include new efficacy data which specify that longer-term treatment with Soliris was associated with a greater proportion of patients achieving clinically significant benefits, as well as new information on the risks associated with treatment discontinuation.
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