A new treatment for splenectomised adult chronic immune (idiopathic) thrombocytopenic purpura, which causes a drop in blood platelet production, has been cleared for use in Europe.
Developed by Amgen, Nplate works by raising and maintaining platelet levels, and represents a new approach for the long-term treatment of this serious autoimmune disorder.
It has been granted marketing authorisation for the EU after being approved by the European Committee for Medicinal Products for Human Use in November last year.
Nplate is a thrombopoiesis-stimulating peptibody that increases platelet production and reduces the need for other ongoing treatment.
In trials, Nplate raised and maintained platelet counts in 83% of patients, and allowed corticosteroids treatments, which are often not well tolerated, to be discontinued.
Studies show that platelet counts were increased by 20,000 per microlitre more than 80% of the time in 47% of patients, and more than half the time in 67% of patients.
Said Amgen’s Willard Dere: “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.”
Copyright Press Association 2009