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news.Symphogen and Swedish Orphan Biovitrum have got orphan drug status for Rozrolimupab (Sym001) as a treatment of primary Immune Thrombocytopenia (ITP) from the US Food and Drug Administration (FDA).
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Swedish Orphan Biovitrum chief scientific officer Peter Edman said that the orphan drug designation provides them with valuable regulatory support for the development of Sym001 in ITP that will be beneficial in ambition to develop this treatment for chronic ITP patients and provide an alternative treatment to them.
Symphogen CEO Kirsten Drejer said that Sym001 is the first ever recombinant polyclonal antibody product to have entered human clinical trials.
“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,” Drejer said.