Nplate romiplostim platelet producer

From Yenra

On February 6, 2009, Amgen announced that the European Commission (EC) has granted marketing authorisation for Nplate (romiplostim) for the treatment of splenectomised adult chronic ITP - idiopathic immune thrombocytopenic purpura patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second line treatment for adult non-splenectomised ITP patients where surgery is contra-indicated.

Nplate, the first and only approved platelet producer in Europe, has been granted marketing authorisation for the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use in November 2008. Nplate works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

Nplate is the first treatment specifically developed for ITP. It is also being investigated for potential use in paediatric ITP, myelodysplastic syndromes (MDS) and chemotherapy-induced thrombocytopenia (CIT).

Nplate was granted approval for ITP by the regulatory bodies in Australia in July and the United States (U.S.) in August 2008. Amgen has filed for regulatory approval of Nplate in Canada and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006).