Novartis announces long-term safety data of Revolade® in adults with chronic immune thrombocytopenia

novartis

June 10, 2016

Novartis has announced data from the largest study of its kind confirming the long-term safety profile of Revolade (eltrombopag) in adults suffering from chronic immune (idiopathic) thrombocytopenia (ITP), with data for up to 6 years in some patients (median exposure was 2.4 years). More data from the study would also show that long-term oral administration of Revolade was effective in increasing and maintaining platelet counts in adult patients who had their spleens removed (splenectomized) as well as those who did not (non-splenectomized). Final results of the study and sub-analysis will be presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.

ITP is a potentially serious and rare type of blood disorder where the blood doesn’t clot as it should because of a low number of platelets. Consequently, patients experience bleeding, bruising, and in some cases, serious hemorrhage that can be deadly. ITP may also affect the quality of life of the patients, as it is often associated with depression and fatigue, as well as a fear of bleeding that may limit everyday activities.

“Patients living with chronic diseases will likely remain on therapy for many years, so data about the long-term use of treatments, particularly around safety, are critical. EXTEND is the largest study of its kind and reinforces Revolade as a trusted option that adults with chronic ITP can use for the long-term,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.

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