Amgen Submits Supplemental Biologics License Application For Nplate ® (romiplostim)

Application Seeks to Include Adult Patients who Have had Immune Thrombocytopenia for 12 Months or Less THOUSAND OAKS, Calif., Dec. 19, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Nplate® (romiplostim) to include the treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy. "Patients living with ITP need more flexibility in their treatment options, and we believe Nplate has the potential to play a role earlier in the paradigm," said...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news