Hansa Medical receives FDA Orphan Drug Designation for IdeS and the treatment of Guillain-Barré syndrome

February 16, 2018

Hansa Medical today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IdeS (INN: Imlifidase) for the treatment of Guillain-Barré syndrome (GBS).

Hansa Medical, a Swedish company, is developing a drug, IdeS, which inactivates IgG. This inactivation would be like an instant plasmapheresis treatment. In February 2017, preclinical data from Hansa Medical showed that in an animal model of GBS, inactivation of IgG by IdeS treatment significantly promoted the recovery and reduced the degeneration of peripheral nerves. These data suggest that treatment with IdeS could potentially become a novel therapeutic strategy for the treatment of GBS. Several members of our GMAB are working with Hansa Medical to develop a study in GBS

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More information about the ODD has been posted on .