April 19, 2016
Amgen has announced that The Lancet published results from a Phase 3 randomized, double-blind, placebo-controlled study of Nplate® (romiplostim) in children with symptomatic immune thrombocytopenia (ITP). According to the study, 52 percent of Nplate patients achieved a durable platelet response, compared with 10 percent of placebo-treated patients (p=0.002, odds ratio 9.1, 95 percent CI: 1.9, 43.2). Moreover, Nplate reduced rates of bleeding by more than 30 percent in children affected by blood disorder.
“Children with ITP are at risk for serious bleeding events due to low platelet counts, which can be very frightening for these children and their parents. The results of this study suggest that romiplostim could reduce the frequency and severity of bleeding events for children suffering from symptomatic ITP, thus providing them with another potential treatment option,” said Michael D. Tarantino, M.D., The Bleeding and Clotting Disorders Institute, professor of Pediatrics and Medicine, University of Illinois College of Medicine-Peoria, Peoria, Illinois.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “Nplate helps bone marrow produce more platelets, which in turn helps prevent bruising and bleeding which is important for children faced with this condition. These data are important in understanding how Nplate may play a role in helping children manage this disease. We will work with regulatory authorities towards an approval for Nplate for pediatric patients.”