BioMarin and Genzyme file to market Aldurazyme in Europe

Published: 17-May-2002
Regulatory


US companies BioMarin Pharmaceutical and Genzyme General have filed a marketing authorisation application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) for Aldurazyme (laronidase), an investigational enzyme replacement therapy for patients with the life-threatening genetic disease mucopolysaccharidosis I (MPS I).

The EMEA's Committee for Proprietary Medicinal Products (CPMP) will now evaluate the application to determine whether to approve Aldurazyme for the treatment of MPS I in all 15 EU member states.

The MAA contains data from a Phase III clinical trial of Aldurazyme, involving 45 patients at five sites in the US, Europe and Canada. The randomised, double-blind, placebo-controlled study showed a statistically significant increase in pulmonary capacity, and demonstrated a positive trend in endurance.

BioMarin and Genzyme General formed a joint venture in 1998 to develop and commercialise Aldurazyme worldwide. The companies have received Orphan Drug designation and Fast Track status for Aldurazyme for MPS I from the FDA and orphan medicinal product designation from the EMEA.

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