Breaking News, Trials & Filings

Sobi Receives IND Acceptance from FDA

The company was also granted Fast Track status for the drug candidate SOBI003

Swedish Orphan Biovitrum (Sobi) has announced that the FDA has accepted their 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 s...

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