Sobi Receives IND Acceptance from FDA

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 status granted by the FDA. It is an important step towards initiating the first clinical study with SOBI003 in children affected by MPS IIIA. The Fast Track status granted by the FDA is a milestone and acknowledgement of the significant unmet medical need that SOBI003 may be fulfilling", says Milan Zdravkovic, chief medical officer and head of Research and Development at Sobi.

The clinical study with SOBI003 is expected to start during 2018.