UK NICE gives final yes for Amgen's Nplate but no for PharmaMar's Yondelis

27 April 2011

There was mixed news this morning from the UK’s drug rationing body the National Institute for Health and Clinical Excellence (NICE) for US biotechnology giant Amgen (Nasdaq: AMGN) and Spain’s PharmaMar, a subsidiary of Zeltia (ZEL: MC).

The NICE has recommended Amgen’s Nplate (romiplostim) for the treatment of patients with severe, chronic immune (idiopathic) thrombocytopenic purpura (ITP), a rare bleeding disorder in which the immune system destroys platelets, which are needed for normal blood clotting. People with the disease have abnormally low levels of platelets in the blood. The condition is currently thought to affect 3,000-3,500 people in the UK; some patients may only have the condition for a short period of time, but when a patient has ITP for over 12 months this is defined as having chronic ITP.

In this final guidance, the NICE says that only a hematologist should initiate and supervise treatment with romiplostim, which is recommended for the treatment of adults with chronic ITP:

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