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UPDATE 1-Glaxo blood platelet booster recommended in Europe
December 18, 2009 / 12:46 PM / 8 years ago

UPDATE 1-Glaxo blood platelet booster recommended in Europe

* Revolade endorsed by European Medicines Agency

* Will compete with Amgen’s already-approved Nplate

(Adds details on drug and competition)

LONDON, Dec 18 (Reuters) - GlaxoSmithKline’s (GSK.L) drug Revolade has been recommended for approval in Europe to treat a rare clotting disorder that can cause dangerous bleeding, the European Medicines Agency said on Friday.

The drug helps stimulate bone marrow into producing blood platelets in patients with chronic immune thrombocytopenic purpura (ITP).

ITP occurs when the immune system destroys platelet cells that help the blood clot and low platelet levels can trigger life-threatening bleeding. Patients with the condition are also more likely to experience bruising.

Glaxo’s oral drug, which is also known as Promacta and is already approved in the United States, will compete with Amgen’s (AMGN.O) injectable product Nplate, which won full European approval in February.

Analysts expect Glaxo’s medicine to generate worldwide sales of $260 million in 2012, according to consensus forecasts from Thomson Pharma.

Recommendations for marketing approval by the EU drug agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Revolade was discovered as a result of a research collaboration between Glaxo and Ligand Pharmaceuticals (LGND.O). (Reporting by Ben Hirschler; Editing by Greg Mahlich)

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