FDA responds on Fabrazyme
Executive Summary
Genzyme receives "complete response" letter for Fabrazyme (agalsidase beta) Oct. 19. FDA letter requests additional data but does not raise any "new issues," company says. TKT is still waiting to hear on competing Fabry disease treatment Replagal (agalsidase alpha). Both companies submitted additional information to FDA in April
Genzyme receives "complete response" letter for Fabrazyme (agalsidase beta) Oct. 19. FDA letter requests additional data but does not raise any "new issues," company says. TKT is still waiting to hear on competing Fabry disease treatment Replagal (agalsidase alpha). Both companies submitted additional information to FDA in April. |