fda-approval-letter
PHARMACY

Amgen’s Nplate pediatric indication gets FDA approval

BY Sandra Levy

Amgen has received the Food and Drug Administration’s blessing for Nplate (romiplostim) for the treatment of pediatric patients age 1 year old and older with immune thrombocytopenia, or ITP, for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

ITP is a rare, serious autoimmune disease characterized by low platelet counts in the blood and impaired platelet production.

Nplate is a thrombopoietin, or TPO, receptor agonist that mimics the body’s natural TPO, and is designed to increase platelet counts in patients with chronic IPT.

“Today’s approval underscores our long-standing commitment to making a positive impact on the lives of patients with rare and difficult to treat hematological disorders,” David Reese, Amgen’s executive vice president of research and development, said. “In the 10 years since the FDA approved Nplate as the first platelet booster for adult patients with chronic ITP, it has made a difference in the lives of thousands of adults, and we’re proud to bring this treatment option to children who need it most.”

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