Human therapeutics company Amgen (NASDAQ:AMGN) disclosed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for its Supplemental Biologics License Application (sBLA) for Nplate for treating immune thrombocytopenia (ITP).

The company said the sBLA for Nplate (romiplostim) included new data in its US prescribing information showing sustained platelet responses in adults with immune thrombocytopenia (ITP), a rare, serious autoimmune disease characterized by low platelet counts.

According to the company, the Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with ITP.

Following approval of the updated indication, the company now expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The FDA earlier approved another sBLA for Nplate in the treatment of pediatric patients with ITP.

This sBLA was based on the company's Phase 2 study was a single-arm, open-label study designed to assess the safety and efficacy of Nplate in adult patients who had an insufficient response to first line therapy. About 32% of patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial and 93% of patients achieved a platelet response.