Shire Pharmaceuticals files Elaprase with FDA

British-based Shire Pharmaceuticals has applied for a biologics licence application with the Food and Drug Administration (FDA) for idursulfase, also known as Elaprase.

If the drug is approved by the FDA, Shire says that it will become the first human enzyme replacement therapy available for Hunter syndrome. The FDA had previously given idursulfase fast track designation, and Shire has requested that the drug is given a priority review.

The application includes study data of 92 patients, and found that those who received the drug achieved more statistically significant improvements during six minute walk tests than those who had only received a placebo.

“Our filing with the FDA is a milestone for Shire and our team, who have been steadfast in the research and development of this much needed treatment,” said Dr David D Pendergast of Shire human genetic therapies.

“We are now a significant step closer to helping patients and their families living with Hunter syndrome, and I am pleased that this application has been submitted on schedule and I look forward to approval and subsequent launch in 2006.”

Hunter syndrome is a hereditary illness, where patients produce less of the enzyme iduronate sulfatase than they need to. The enzyme is essential in breaking down mucopolysaccharides, a complex carbohydrate found around most cells.

The syndrome causes the chemical to build up causing abnormal organ function, distinct facial features and in some cases death.

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