sabato, 5 dicembre 2020
17 Dicembre 2018

FDA Approves Romiplostim for Pediatric ITP

December 14, 2018 – The FDA has approved romiplostim for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval is based on 2 double-blind, placebo-controlled trials in this patient population. The first study (NCT01444417) randomized 62 patients with relapsed/refractory disease following ≥1 previous ITP … (leggi tutto)