The Committee for Medicinal Products for Human Use (CHMP) recommends Nplate for adult chronic immune thrombocytopenia purpura (ITP) splenectomised patients who are refractory to other treatments. Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated, the company said.
The CHMP positive opinion 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 splenectomised and non-splenectomised groups when treated with Nplate.
Willard Dere, senior vice president and international chief medical officer of Amgen, said: “Nplate will address an unmet medical need for thousands of patients in the EU as it is a unique treatment option that increases platelet production and avoids immune suppression in adult chronic ITP patients.”