Transkaryotic receives fast track for MPS II drug

Published: 19-Jul-2004

Transkaryotic Therapies has received fast track designation from the FDA for iduronate-2- sulfatase (I2S) to treat Hunter syndrome (MPS II).


Transkaryotic Therapies has received fast track designation from the FDA for iduronate-2- sulfatase (I2S) to treat Hunter syndrome (MPS II).

TKT commenced a pivotal study with I2S in September 2003. The study, referred to as AIM (Assessment of Iduronate-2-sulfatase in MPS II) is a twelve-month, randomised, double-blind, placebo-controlled trial evaluating I2S in 96 patients. TKT expects top-line results from the AIM study in the second quarter of 2005 and, if positive, the company expects to submit applications for marketing approval in both the United States and Europe in the second half of 2005.

'We are pleased that the FDA has given I2S this important designation,' said Michael J. Astrue, president and chief executive officer of TKT. 'We are committed to bringing this treatment to patients as quickly as possible.'

  

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