GSK Drug Gets EC Approval - Analyst Blog

GlaxoSmithKline Plc. (GSK) recently received good news in the form of European approval for its oral thrombopoetin agonist, Revolade (eltrombopag). The European Commission (EC) granted marketing approval to the product for the oral treatment of thrombocytopenia or reduced platelet count in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). 

Revolade was granted marketing authorization in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, like corticosteroids and immunoglobulins therapies. Revolade also gained approval for use as a second-line treatment option for adult patients who cannot get their spleen removed due to contraindications. 

Revolade’s approval in the EU does not come as a surprise as the product had already received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in Jan 2010. 

Revolade enjoys orphan designation in the EU for the treatment of ITP and is already approved in several countries including the US, where it is marketed under the trade name, Promacta. 

Revolade/Promacta was discovered under research collaboration between Glaxo and Ligand Pharmaceuticals (LGND). Glaxo is also studying Promacta in hepatitis-C related thrombocytopenia and in early Nov 2007 announced the commencement of two phase III studies, ENABLE 1 and ENABLE 2, to evaluate the ability of Promacta/Revolade to sufficiently raise platelet counts in order for patients with hepatitis-C related thrombocytopenia to undergo antiviral therapy. Glaxo is studying Revolade/Promacta for the treatment of chronic liver induced thrombocytopenia as well. 

We believe Promacta/Revolade offers excellent potential in both idiopathic thrombocytopenic purpura and hepatitis-C related thrombocytopenia (phase III). The drug should have £1 billion peak potential, but will compete with Amgen’s (AMGN) Nplate. 

We currently have an Underperform recommendation on Glaxo. Although Glaxo boasts of a diversified base and presence in different geographical areas, we remain concerned about the patent challenges being faced by several of its products. With several products expected to lose exclusivity and the swine flu opportunity likely to miss expectations, we expect Glaxo’s top-line to remain under pressure in the coming quarters.
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