GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®

GlaxoSmithKline plc announced today that it has submitted regulatory applications in the European Union and United States related to eltrombopag (Promacta®/Revolade® ) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia), specifically,

• a variation to the Marketing Authorisation Application to the European Medicines Agency for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferonbased therapy.
• a supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimise interferonbased therapy.

About eltrombopag (Promacta®/Revolade®)

Eltrombopag, known by the brand name Promacta in the United States and Revolade in the European Union and other countries, is currently approved in 88 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia.

Important Safety Information

Promacta may cause hepatotoxicity. Other risks for Promacta include: bone marrow reticulinformation and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts.

For more important safety information about the currently licensed indications forPROMACTA/Revolade, please visit Revolade – Prescription medicines – Our products -GlaxoSmithKline to view the Revolade EU Patient Information Leaflet and visit Promacta – Prescription medicines – Our products – GlaxoSmithKline for full Promacta US Prescribing Information including BOXED WARNING risk for hepatotoxicity.