NEW YORK (March 20, 2009) -- Patients suffering from a blood disorder that prevents proper clotting have the option of a new medication that may dramatically improve their health. There are estimated to be between 50,000 and 100,000 individuals in the U.S. diagnosed with chronic immune thrombocytopenic purpura (ITP), an autoimmune disease that dramatically reduces the number of platelets in their blood -- causing bruises, nosebleeds and, rarely, life-threatening brain hemorrhages.
Promacta (eltrombopag) was granted accelerated approval by the U.S. Food and Drug Administration in November 2008 for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promising results of an international, multicenter Phase III clinical trial, led by NewYork-Presbyterian/Weill Cornell researchers, were the basis of this approval and are published in a recent issue of the Lancet.
"Findings from the new study are very encouraging, and I believe this treatment is an effective option for all patients suffering from chronic ITP," says Dr. James Bussel, principal investigator of the study; attending pediatrician and director of the Program for Platelet Disorders at NewYork-Presbyterian Hospital/Weill Cornell Medical Center; and professor of pediatrics, and professor of pediatrics in medicine at Weill Cornell Medical College.
The study follows a previous Phase II study published late 2007 in the New England Journal of Medicine. This trial showed that eltrombopag was effective in raising platelet counts and lowering bleeding in adult subjects with chronic ITP. The Phase II study's results also determined the most promising dose of 50mg, which was given to all of the experimental subjects in the Phase III study.
The Phase III study tested 114 subjects, who were all 18 years and older, with at least six mont
|Contact: Andrew Klein|
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College