GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade)

EMA

GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade), seeking an additional indication for the treatment of paediatric patients (age 1 year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins.

Characterised by a low platelet count, ITP affects as many as 5 in 100,000 children each year. While many children with acute ITP do not require treatment and/or their disease resolves, up to 30 percent of patients experience persistent disease at 12 months and are diagnosed with chronic ITP.2,3,4 Patients with paediatric chronic ITP are at a risk of severe bleeding.

For more details, go to: http://www.gsk.com/en-gb/media/press-releases/2015/gsk-announces-eu-regulatory-submission-seeking-additional-indication-for-eltrombopag-revolade/

Michael Wonder

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Michael Wonder

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