Amgen Inc. has received the Prix Galien USA 2009 Award for Best Biotechnology Product for Nplate® (romiplostim), the first FDA approved peptibody protein and the first treatment specifically developed for chronic immune thrombocytopenic purpura (ITP), a serious autoimmune disorder.
The Prix Galien award is the industry’s highest accolade for pharmaceutical and biotechnology research and development. For more information about the award, please click here.
Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.
IMPORTANT SAFETY INFORMATION
Serious adverse reactions associated with Nplate® in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate® discontinuation. Additional risks include Bone Marrow Fibrosis, Thrombotic/Thromboembolic Complications, Lack or Loss of Response to Nplate®, Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS).
Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.
Monitor CBC’s, including platelet counts and peripheral blood smears, prior to initiation, throughout, and following discontinuation of Nplate® therapy.
Nplate® is available only through a restricted distribution program called Nplate® NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program.
In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.