FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP

Nplate™ (romiplostim) is the first and only platelet producer approved by the U.S. Food and Drug Administration for the long-term treatment of adult chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events and significantly impact patients’ lives. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the United States and is considered an unmet medical need by the FDA.

First FDA Approved Peptibody Protein

The peptibody is a novel platform developed by scientists at Amgen. A peptibody is an engineered protein, made by recombinant DNA technology, with attributes of both peptides and antibodies, but is distinct from each. The Nplate peptibody protein has been designed to bind to the TPO receptor thereby stimulating platelet production.