The U.S. global biopharmaceutical company Amgen Inc. (NASDAQ:AMGN) informed the market Wednesday that it submitted to the US Food and Drug Administration FDA a supplemental Biologics License Application (sBLA) for one of its drugs.
Amgen is seeking approval to use its drug romiplostim (Brand name Nplate) to treat adult patients who are affected with an immune thrombocytopenia disorder for no more than one year. The treatment is for those who have not responded adequately either to a therapy based on corticosteroids and immunoglobulins or to splenectomy.
The U.S. agency already approved Amgen’s Nplate in August 2008 for the treatment of adult patients of immune thrombocytopenia over the long run.
Nplate is a hormone that regulates the production of platelets in the serum. The medication is administered through a subcutaneous injection.
Thrombocytopenia is a condition in which the patient shows abnormally low levels of platelets in the blood. In immune thrombocytopenia there is a massive destruction of platelets due to immune conditions. These immune conditions are several and range from immune and thrombocytopenic purpura to Gaucher’s disease and infections with the dengue and Zika viruses.