MARTINSRIED (dpa-AFX) - MorphoSys AG (MPSYY.PK) announced that it has received a positive opinion from the European Medicines Agency or EMA on the application for orphan medicinal product designation for MOR208, MorphoSys' humanized Fc engineered monoclonal antibody against CD19, for the treatment of diffuse large B-cell lymphoma or DLBCL.
The company said the positive opinion is to be adopted by the European Commission. Earlier in December the company had also received the orphan drug designation by the Food & Drug Administration for MOR208 in the same indication.
Orphan drug and orphan medicinal product status are granted by the US and European health authorities respectively to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the US annually and no more than five in 10,000 people in the European Union.
Commenting on MOR208, the company said it is an Fc-enhanced, humanized monoclonal antibody targeting the antigen CD19, which is being developed for the treatment of B-cell malignancies. The program is currently in phase 2 clinical development in chronic lymphocytic leukemia or CLL, acute lymphoblastic B-cell leukemia or B-ALL and non-Hodgkin's lymphoma or NHL.
Copyright RTT News/dpa-AFX