Emergent Receives Orphan Medicinal Product Designation from European Commission for TRU-016 for CLL

Emergent BioSolutions

today announced that the European Commission granted orphan medicinal product designation to Emergent's humanized single chain monoclonal antibody against CD37, also called TRU-016, for the treatment of chronic lymphocytic leukemia (CLL). “Receiving orphan medicinal product designation for TRU-016 from the European Commission, following orphan drug designation from the FDA in 2011, is an important step in the development of TRU-016 and underscores the medical need in treating B-cell malignancies like CLL,” said Scott C. Stromatt, M.D., senior vice president and chief medical officer of Emergent BioSolutions. “Emergent is pleased to receive these designations and we are looking forward to data from our ongoing CLL studies.”