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news.Amgen has announced that the European Commission has granted marketing authorization for Nplate for the treatment of splenectomized adult chronic immune thrombocytopenic purpura patients who are refractory to other treatments.
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Nplate may be considered as second line treatment for adult non-splenectomized immune thrombocytopenic purpura patients where surgery is contra-indicated.
According to the company, Nplate, the first and only approved platelet producer in Europe, has received marketing authorization from the EU based upon a positive opinion from the European Committee for Medicinal Products for Human Use in November 2008.
The EU approval of Nplate is based on data from two separate placebo-controlled Phase III studies, demonstrating that platelet counts were raised and sustained in 83% of patients for both splenectomized and non-splenectomized groups when treated with Nplate.
Willard Dere, senior vice president and international chief medical officer of Amgen, said: “The European approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first approved peptibody, an innovative platform for delivering targeted therapies.”