Shire's Elaprase gets EU OK for Hunter synd

UK-based drugmaker Shire says that the European Commission has granted its drug Elaprase (idursulfase) marketing authorization for use as a treatment for patients with Hunter syndrome (mucopolysaccharidosis II). The company added that the agent, which is the first and only enzyme replacement therapy for people suffering from the condition, is being discussed in terms of pricing and reimbursement in many European countries, and is scheduled for launch this year.

Elaprase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, that is produced using a recombinant DNA technology and Shire's human cell line. The drug is delivered via weekly infusions, and functions by replacing the defective or missing enzyme in patients suffering from the disease.

Shire went on to say that, to date, more than 200 patients are receiving the drug, 100 of whom are part of a Europe-wide pre-approval access program, with the remainder being in the USA, where the drug was launched last year (Marketletter July 31, 2006).