Amgen has received a welcome boost from panellists at the US Food and Drug Administration who have recommended approval for the firm’s new blood-clotting drug Nplate.

The agency’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of Nplate (romiplostim), a investigational thrombopoietin mimetic peptibody, for the treatment of chronic immune thrombocytopenic purpura (ITP). The latter is a rare blood disorder characterised by increased platelet destruction or inadequate platelet production, which causes an increased risk of bruising and bleeding.

Ahead of the ODAC meeting, FDA staffers had expressed concerns about the product, including an increase in bone marrow fibres known as reticulin, an increase in blood clots and the development of resistance to the treatment. They also questioned whether the compound may cause or contribute to other blood disorders, such as leukaemia, due to its mechanism of action.

However they have decided that the benefits of the drug outweigh the risks after Amgen has proposed a risk-management programme that would restrict distribution to doctors treating patients with ITP in hopes it would discourage off-label use. Amgen will also run postmarketing studies on Nplate to monitor adverse events.

Amgen now expects approval for Nplate in the next few months and analysts have forecast that sales next year should be in the region of $120 million.