Amgen Inc. said the U.S. Food and Drug Administration approved Nplate to treat a rare bleeding disorder in children who are one year old and older.
Nplate, or romiplostim, is now approved to treat children with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Immune thrombocytopenia is an autoimmune disease characterized by low platelet counts in the blood and impaired platelet production and can lead to easy or excessive bruising and bleeding. According to the National Organization for Rare Disorders, the estimated prevalence of the disease in the U.S. in children is 5.3 per 100,000 children.
Nplate is already approved by the FDA for adult patients with chronic immune thrombocytopenia.
The Thousand Oaks, Calif.-based company said the most recent approval is based on two trials in children, which showed that Nplate resulted in a higher and more durable improvement in platelet count compared with placebo.