Company News: SuppreMol Receives U.S. Orphan Drug Designation for SM101
SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).
At present, SM101 is in a Phase Ib/IIa clinical study in ITP, with results expected in early 2011. For the same indication, the molecule has already been granted Orphan Medicinal Product Designation in Europe by the EU Commission in 2007. Further details are available on the company’s website.
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