Amgen today announced that the U.S. Food and Drug Administration (FDA) approved Amgen's Supplemental Biologics License Application (sBLA) for Nplate® (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia (ITP), a rare, serious autoimmune disease characterized by low platelet counts. The updated indication expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. In December of last year, the FDA approved another sBLA for Nplate in the treatment of pediatric patients with ITP.
"These new data are the first of their kind to prospectively examine treatment-free remission as an outcome for patients with ITP. Thirty-two percent of patients who received Nplate soon after an insufficient response to the first course of steroids maintained platelet response for at least six months without Nplate or any other ITP therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This approval will provide patients the opportunity to receive Nplate earlier in the course of their disease, potentially reducing their need for prolonged steroid use.
- From Amgen press release