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Home Industry News GSK presents safety and efficacy data for Promacta

GSK presents safety and efficacy data for Promacta

13th December 2007

GlaxoSmithKline (GSK) has presented data on the long-term safety and efficacy of its investigational drug Promacta (eltrombopag) for the treatment of chronic idiopathic thrombocytopenic purpura (ITP).

Preliminary results were announced at the American Society of Haematology Annual Meeting this week and revealed that patients with chronic ITP increased and maintained platelet counts at more than or equal to 50,000 per microlitre with extended treatment.

GSK has stated that the results suggest that Promacta sustains increased platelet counts during long-term treatment.

The study also shows Promacta to be well tolerated with 83 per cent of the 94 patients administered with the drug reporting at least one adverse event (AE).

Just over a third of patients reported a drug-related AE and 12 per cent reported serious AE.

James B Bussel, director of the Platelet Disorders Center in New York, commented on the study: “These long-term results on safety and efficacy are encouraging and suggest that Promacta, once approved, may provide physicians with a new treatment option to raise and maintain patients’ platelet levels and alleviate their ITP symptoms.”

Chronic ITP is a disorder characterised by low levels of platelets in the blood which can lead to bleeding and bruising as well as possible fatal hemorrhages.

GSK has also this week announced the formation of a multi-year strategic alliance with Galapagos NV to develop anti-infective drug candidates

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