Amgen Submits MAAs to EMA for Two Investigational Drugs
Amgen has submitted separate marketing authorization applications (MAA) for two new investigational drugs, talimogene laherparepvec and evolocumab, to the European Medicines Agency (EMA) via the centralized procedure.
Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection for treating adults with melanoma that is regionally or distantly metastatic. The MAA submission follows a submission of a biologics license application (BLA) to the US Food and Drug Administration. Talimogene laherparepvec is designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor’s cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Amgen has also submitted a MAA to the EMA via the centralized procedure for evolocumab for treating high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. The company recently filed a BLA with the US FDA.