Shire announces authorisation for Elaprase

Shire has announced today that it has received marketing authorisation from the European Commission for the administration of Elaprase (idursulfase) to offer long-term treatment for patients with Hunter syndrome (Mucopolysaccharidosis II).

Elaprase is produced by recombinant DNA technology in human cell lines and is a purified version of the lysosomal enzyme iduronate-2 sulfatase (12s). The compound previously received a positive opinion from the Committee for Medicinal Products for Human Use in October last year.

Patients with Hunter syndrome lack the 12s enzyme necessary for the body’s breakdown of some complex carbohydrates, known as glycosaminoglycans. Elaprase, administered through weekly infusions, replaces this missing enzyme.

Matthew Emmens, chief executive officer of Shire, said: “We are very pleased with this next step in the global development of Elaprase.

“Hunter syndrome is a rare and devastating condition”

He added that the availability of Elaprase would have a large impact on the lives of patients suffering from the disease.

In December, Shire announced that the regulating agencies for a number of European countries had agreed on core labelling information forming part of the company’s market authorisation application for Mezavant, allowing the company to make a phased launch of the compound in Europe.