Revolade variation filed with EMA for Severe Aplastic Anaemia-GSK
Glaxo Smith Kline has announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for Revolade (eltrombopag), seeking an additional indication for the treatment of adult patients with severe Aplastic Anaemia who have had an insufficient response to immunosuppressive therapy. The EMA submission is based on the results of a pivotal open-label Phase II study (ELT112523) and two supporting Phase II studies (ELT116826 and ELT116643) by the National Institute of Health evaluating eltrombopag in patients with SAA.
In August 2014, the drug - marketed as Promacta - was approved by the FDA for once-daily use in patients with SAA who have had an insufficient response to IST.
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