Amgen says FDA approves Nplate for use in pediatric patients with ITP - InvestingChannel

Amgen says FDA approves Nplate for use in pediatric patients with ITP

Amgen announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Nplate for the treatment of pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The approval was based on two placebo-controlled studies – Phase 3 and Phase 1/2 – evaluating the safety and efficacy of Nplate in pediatric patients. In the Phase 3 study, published in The Lancet, rates of overall platelet response were increased with the Nplate group compared with placebo, pless than0.05. Additionally, durable platelet response occurred more frequently with Nplate compared with placebo, pless than0.05. In the two placebo-controlled trials, adverse reactions with an incidence of greater than 25 percent in the Nplate arm were contusion, upper respiratory tract infection and oropharyngeal pain.