The US FDA approves GSK’s promacta for hepatitis C

Hannah Blake

pharmaphorum

The US FDA has approved GlaxoSmithKline’s promacta for the additional use of treating hepatitis C patients with a low platelet count who are unable to undergo standard hepatitis C therapy.

Promacta (eltrombopag) is the first supportive care treatment approved for patients with thrombocytopenia with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. In combination with interferon-based therapy, promacta has been shown to improve a patient’s chance of achieving a sustained virologic response (SVR) or viral cure.

“Chronic hepatitis C is a significant public health issue. Some chronic hepatitis C patients suffer from low blood platelet counts. Commonly prescribed interferon-based therapies can worsen the problem of low blood platelet counts. Today’s FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge. This means more chronic hepatitis C patients may be able to start and stay on interferon-based therapy. That gives these patients a better chance to achieve a viral cure.”

Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology.

Eltrombopag is marketed under the brand names promacta, in the US, and revolade in Europe and the rest of the world. It is a thrombopoietin receptor agonist approved in 90 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). This additional usage approval in the United States will enable doctors to address the low platelet challenge in patients with chronic hepatitis C.

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