New Zealand and Iceland approve TKT's Replagal

Transkaryotic Therapies has received marketing approval for its enzymereplacement therapy Replagal (agalsidase alfa), for the long term treatment of Fabry disease, in New Zealand and Iceland.

The approval was based on trial data which demonstrated multiple clinical improvements, including a reduction in neuropathic pain and reduction in the use of pain medications, initial stabilization followed by improvement in kidney function, a reduction in cardiac mass, and a metabolic correction of glycosphingolipid levels in urine sediment, plasma, and kidney, heart and liver cells.