TKT's Hunter syndrome therapy on fast-track

Transkaryotic Therapies says that it has received fast-track designationfrom the US Food and Drug Administration for its recombinant iduronate-2-sulfatase as a treatment for Hunter syndrome (MPS II).

The US firm began a pivotal trial of the product last year (Marketletter September 29, 2003). The study, designated AIM (Assessment of Iduronate-2-sulfatase in MPS II), is a 12-month, randomized, double-blind, placebo-controlled trial involving 96 patients. TKT hopes to submit filings in the USA and European Union in the second half of 2005, subject to positive findings from the AIM study.