Posted by Michael Wonder on 18 Oct 2019
Nplate (romiplostim) now approved for earlier use in adults with immune thrombocytopenia
18 October 2019 - Amgen today announced that the U.S. FDA approved Amgen's supplemental biologics license application for Nplate (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia (ITP), a rare, serious autoimmune disease characterised by low platelet counts.
The updated indication expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
In December of last year, the FDA approved another application for Nplate in the treatment of paediatric patients with ITP.
