Shire Pharmaceuticals files idursulfase with EMEA

Shire Pharmaceuticals has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for idursulfase for the treatment of Hunter syndrome.

A review of a MAA by EMEA typically takes 12 months. However, if approved, this would be the first human enzyme replacement therapy for the treatment of Hunter syndrome, also known as mucopolysaccharidosis II (MPS II).

“Following last week’s filing in the United States, our MAA filing with the EMEA is another key milestone in bringing to market a treatment for patients and families around the world living with Hunter syndrome,” said Dr David Pendergast, executive vice president and general manager of Shire Human Genetic Therapies, the Shire specialty unit focused specifically on genetic diseases.

Shire has already filed idursulfase under the tradename Elaprase with the US Food and Drug Administration (FDA) under a Fast Track designation and has requested Priority Review of that submission, which would result in a six-month FDA review.

Hunter syndrome is a rare, life threatening, genetic disorder with no available treatment.

Often the first symptoms may include hernias, frequent ear infections, runny noses, reduced growth rate and abnormal facial appearance.

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