Andelyn Biosciences begins commercial manufacturing of Fayuvi gene therapy

Andelyn Biosciences has commenced commercial manufacturing of Fayuvi (rebisufligene etisparvovec-hopf), an FDA-approved gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA). The manufacturing is taking place at Andelyn’s facility in Columbus, Ohio.

Developed by Ultragenyx Pharmaceutical Inc., Fayuvi is the first FDA-approved gene therapy to be produced using the Andelyn AAV Curator Platform process. The therapy is also being manufactured at Ultragenyx’s facility in Bedford, Massachusetts.

Sanfilippo syndrome type A is a rare, fatal lysosomal storage disease that causes rapid neurodegeneration in early childhood. It is estimated to affect between 3,000 and 5,000 patients globally, with a median life expectancy of 15 years.