Symphogen and Swedish Orphan Biovitrum receive U.S. orphan drug designation for Rozrolimupab in ITP
Symphogen and Swedish Orphan Biovitrum announced that the United States food and Drug Administration (FDA) has granted Orphan Drug Designation to rozrolimupab (Sym001) for the treatment of primary Immune Thrombocytopenia (ITP). ITP is an autoimmune bleeding disorder characterized by abnormally low platelet levels, making it difficult for the blood to clot normally.
"Orphan drug designation provides us with valuable regulatory support for the development of Sym001 in ITP that will be beneficial in our ambition to develop this innovative treatment for chronic ITP patients and provide an alternative treatment to them," says Peter Edman, Chief Scientific Officer, Swedish Orphan Biovitrum.
"Sym001 is the first ever recombinant polyclonal antibody product to have entered human clinical trials," stated Kirsten Drejer, PhD., Chief Executive Officer of Symphogen. "Sym001 is currently being studied in a Phase II dose finding trial. We intend to develop it as an alternative to plasma derived anti D and immunoglobulins".
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