Nplate treatment raises durable platelet response for children with ITP
In the Phase 3 randomized, placebo-controlled, double-blind study, Nplate successfully decreased the children’s bleeding rates over 30 percent. The results demonstrated to approximately 52 percent of the patients showed a positive durable platelet response; this is a significant increase over the 10 percent of placebo-treated patients involved in the study.
"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," Michael Tarantino, professor of pediatrics and medicine, University of Illinois College of Medicine-Peoria, said. "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."
The results showed that Nplate can meet the primary endpoint for durable platelet response. This discovery will benefit children around the world.
"Nplate helps bone marrow produce more platelets, which in turn helps prevent bruising and bleeding which is important for children faced with this condition,” Sean Harper, executive vice president of research and development at Amgen, said. “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."