Posted by Michael Wonder on 23 Jan 2018
FDA accepts investigational new drug application and grants fast track status for SOBI003 for the treatment of MPS IIIA
23 January 2018 - Swedish Orphan Biovitrum announces that the FDA has issued a study may proceed letter for the first study in humans, thereby accepting the investigational new drug 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.
The clinical study with SOBI003 is expected to start during 2018.
