Shire submits marketing application for Hunter Syndrome in Europe

By Angela McDaniels

Seattle, Dec. 1 - Shire plc said it has submitted a Marketing Authorization Application to the European Medicines Agency for idursulfase (Elaprase) for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II.

Application review typically takes 12 months. If approved, this would be the first therapy developed to replace the missing enzyme of patients with Hunter syndrome, the company said.

If idursulfase gains approval, Shire plans to launch the drug is Europe in late 2006 or early 2007.

Shire filed idursulfase with the U.S. Food and Drug Administration on Nov. 23 under a Fast Track designation and has requested priority review of this submission, which would result in a six-month review.

Elaprase is a human iduronate-2-sulfatase produced by genetic engineering technology. It has been designated an orphan drug in both the United States and in the European Union, the company said.

Hunter syndrome is a rare, life-threatening genetic disorder with no available treatment. Individuals with Hunter syndrome lack the enzyme iduronate-2-sulfatase, which is essential for the continuous replacement and breaking down of glycosaminoglycans, the company said.

Shire said it believes there are 2,000 patients worldwide afflicted with Hunter syndrome in countries where reimbursement may be possible.

Shire is a pharmaceutical company based in Basingstoke, England, with a current focus on developing products in the areas of central nervous system, gastrointestinal, renal diseases and human genetic therapies.

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