Amgen has been given the thumbs-up from regulators in Europe to sell Nplate for the treatment of a rare blood-clotting disorder, thus stealing a march on GlaxoSmithKline/Ligand Pharmaceuticals’ rival drug Promacta.
Specifically, the European Commission has granted marketing authorisation for Nplate (romiplostim) for the treatment of chronic immune thrombocytopenic purpura (ITP) in patients who do not respond sufficiently to current treatments, such as corticosteroids and immunoglobulin. The drug is only approved for use as second-line therapy for adult non-splenectomised ITP patients where surgery is contra-indicated.
The approval is based on two Phase III studies which demonstrated that platelet counts were raised and sustained in 83% of patients for both splenectomised and non-splenectomised groups. Amgen quoted Roberto Stasi of the Regina Apostolorum Hospital in Italy as saying that Nplate is the first approved long-term treatment option in Europe that specifically targets platelet production.
He added that “although ITP affects a limited patient population, it can have a significant impact on patient lives. Nplate represents a potentially high value option”. There are an estimated 50,000 adults with chronic ITP in the European Union.
Willard Dere, international chief medical officer at Amgen, said that the European approval “is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first approved peptibody”. Nplate was approved in the USA last August where it has since been joined on the market by Promacta (eltrombopag).
