Amgen ITP drug ‘offers new treatment option’

Amgen has announced that Nplate (romiplostim) offers adult patients with chronic immune thrombocytopenic purpura (ITP) a new treatment option.

The company said the drug is available for the treatment of thrombocytopenia in splenectomised (spleen removed) and non-splenectomised adults with the condition, offering a novel long-term approach to the disease.

Nplate, a peptibody protein, has been approved by the US Food and Drug Administration as the first and only platelet producer for chronic ITP.

This approval was based on positive safety and efficacy results for the compound from two pivotal phase III clinical studies of both splenectomised and non-splenectomised patients with the condition.

David J Kuter, chief of haematology at Massachusetts General Hospital, said: “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.”

He added that prior to the introduction of Nplate, chronic ITP patients has limited treatment options, with many drugs being unsuitable for long-term use as a result of tolerability issues and adverse effects.

In February 2008, Amgen said Nplate has shown a positive efficacy profile in clinical trials, with overall platelet response at 88 per cent and 79 per cent in non-splenectomised and splenectomised patients respectively.