BioMarin's Naglazyme approved in Europe

6 February 2006

The USA's BioMarin Pharmaceutical says that the European Commission has granted marketing authorization for Naglazyme (galsulfase) as a treatment for mucopolysaccharidosis VI (MPS VI).

As the first drug ever approved for the genetic disease, Naglazyme has been granted Orphan Drug status in the European Union, which confers 10 years of market exclusivity. The agent has been approved in the EU's 25 member states, Iceland and Norway for long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPS VI and no additional clinical trials are required. The Novato, California-headquartered drugmaker predicts sales of Naglazyme for 2006 to be in the range of $28.0-$32.0 million.

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