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Drug Development
Positive opinion issued for Naglazyme from European regulatory authority
October 23rd, 2005
BioMarin Pharmaceutical, Inc., (BMRN) said the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has issued a positive opinion on the company's Marketing Authorization Application for Naglazyme (galsulfase) an investigational enzyme replacement therapy for treatment of mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). The committee's proposed label states that Naglazyme is approved in the European Union as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPS VI to treat the clinical manifestations of the disease. All clinical post-authorization...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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