SHIRE'S ELAPRASE APPROVED IN EUROPE
Shire announced that the European Commission has granted a marketing authorization for the use of Elaprase (idursulfase) for the long-term treatment of patients with Hunter syndrome.
Elaprase is the first and only enzyme replacement therapy for people suffering from Hunter syndrome, according to Shire, and it was launched in the U.S. in July 2006. Pricing and reimbursement procedures are already under way for Elaprase in many European countries.
Hunter syndrome is a very rare, life-threatening genetic condition that affects mostly males and results from the absence or deficiency of the lysosomal enzyme iduronate-2-sulfatase. Elaprase, which is delivered via weekly infusions, replaces the missing enzyme.
Roughly 100 patients in Europe have been receiving Elaprase through preapproval access programs. Marketing authorization for Elaprase follows the positive opinion issued by the Committee for Medicinal Products for Human Use in October 2006.