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    +46 8 697 20 00
  • Gerard Tobin

    Head of Investor Relations


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    FDA accepts investigational new drug application and grants Fast Track status for SOBI003 for the treatment of MPS IIIA

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA), a rare metabolic disorder also known as Sanfilippo syndrome type A. “We are very pleased with the IND acceptance and Fast Track status granted by

    FDA grants SOBI003 Orphan Drug Designation for the treatment of MPS IIIA

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the company’s development candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A, a rare metabolic disorder. “We are very pleased with the orphan drug designation from the FDA for SOBI003. MPS IIIA is a severe and debilitating disease, and this development program is an important part of our mission of

    European Commission grants SOBI003 orphan designation for the treatment of MPS IIIA

    Swedish Orphan Biovitrum AB (publ)  (Sobi™) (STO: SOBI) has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). SOBI003 will be included in the EU Community Register of Orphan Medicinal Products. MPS IIIA or Sanfilippo A syndrome is an inherited systemic lysosomal storage disease with a significant central nervous system component. Onset is in early childhood and the

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