FDA Label Update Supports Earlier Use of Romiplostim for ITP

October 18, 2019 – The FDA has approved a supplemental Biologics License Application (sBLA) for romiplostim, updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia (ITP). Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval is based on a phase II trial of … (leggi tutto)