GlaxoSmithKline files for new eltrombopag indications in EU and USA; gains rights to derma products

31 May 2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has submitted regulatory applications in the European Union and USA related to eltrombopag (sold as Promacta in the USA and as Revolade in the European Union) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia).

Specifically, GSK has applied for:

* a variation to the Marketing Authorization Application to the European Medicines Agency for Revolade) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy; and

* a supplemental New Drug Application to the US Food and Drug Administration for Promacta as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimise interferon-based therapy.

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