Alexion Pharmaceuticals, Inc.(NASDAQ:ALXN) Gets EU Approval for therapeutic indication of Soliris Print
By David Fowler   
Friday, 10 April 2015 13:35

Alexion Pharmaceuticals, Inc.(NASDAQ:ALXN) has confirmed that European Commission has given approval to EU label for therapeutic indication of Soliris in treatment of paroxysmal nocturnal haemoglobinuria for including patients without history of transfusion. With the approval, revised Summary of Product Characteristics hints proof of clinical benefit being there in patients having high disease activity such as elevated haemolysis as well as presence of related clinical symptom like fatigue, abdominal pain, haemoglobinuria, shortness of breath, anaemia, dysphagia or erectile dysfunction. 

The update strengthens the fact that transfusions don’t affect underlying disease process in PNH and haemolysis plays key role in disease. The non typical haemolytic uraemic syndrome (aHUS) section of EU label has got updated for including the fresh efficiency data which specifies that long-term treatment with Soliris was related to more proportion of patients getting clinically significant benefits and new information on risks pertaining to treatment discontinuation.

When European Medicines Agency (EMA) had approved Soliris in 2011, the Clinical Particulars section had said that the treatment is recommended for continuing throughout the patient's lifetime until discontinuation is indicated.

The revised label adds that monitoring may not be sufficient for preventing severe thrombotic microangiopathy complications in patients who do not continue with Soliris treatment

Carsten Thiel, Ph.D., SVP, EMEA and Asia-Pacific, Alexion, said that the label updates comprise of vital information which help in optimising care for patients with aHUS and PNH, two very rare as well as life-threatening disorders.

He added patients that for patients having PNH, the new label confirms that patients at high risk of morbidities or premature mortality is likely to get benefit from the treatment.

Shares of the company jumped 2.50% to $181.80.

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