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Alexion Pharma Soliris sBLA gets priority review status from FDA

Alexion Pharmaceuticals has received priority review status for its supplemental biologics license application (sBLA) for Soliris (eculizumab) from the US Food and Drug Administration (FDA).

Soliris (eculizumab) is indicated as a treatment for patients with atypical hemolytic uremic syndrome (aHUS).

Alexion plans to launch the drug for the treatment of aHUS in the US in the fourth quarter of 2011.

Moreover, the European Medicines Agency (EMA) is also reviewing a marketing application for Soliris as a treatment for patients with aHUS in the European Union.