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Home Industry News GSK files for marketing approval of Promacta / Revolade

GSK files for marketing approval of Promacta / Revolade

21st December 2007

GlaxoSmithKline (GSK) has submitted a New Drug Application to the US Food and Drug Administration for the marketing approval of Promacta / Revolade (eltrombopag).

The application follows the release of clinical data showing Promacta / Revolade to significantly raise platelet counts and lower bleeding risk for patients with chronic idiopathic thrombocytopenic purpura (ITP).

If approved, the drug will be the first oral platelet growth factor therapy indicated for use in patients with ITP.

Paulo Paoletti, senior vice-president of the oncology medicine development centre at GSK, highlighted that patients with chronic ITP did not currently have a treatment option that offered the “convenience” of an oral platelet growth factor.

“GSK is pleased with the data provided to support the NDA and hopeful that, if approved, Promacta / Revolade may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease,” he said.

The company has confirmed that it plans to submit a Marketing Authorisation Application for eltrombopag in Europe in 2008.

Earlier this month, GSK announced that it had gained approval from the European commission for a new indication of its HIV fixed-dose combination medicine Combivir for use in children and infants.

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