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BioMarin wins Brazilian approval for mucopolysaccharidosis drug

Naglazyme is also approved by the FDA and the European Commission

US-based BioMarin Pharmaceutical has received marketing approval from ANVISA, Brazil’s National Health Surveillance Agency, for Naglazyme for the treatment of patients with mucopolysaccharidosis VI.

Naglazyme was approved by the FDA in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for mucopolysaccharidosis VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the US and 10 years of market exclusivity in the EU, the company said.

Stephen Aselage, senior vice president of global commercial development at BioMarin, said: Although there is no formal orphan drug designation in Brazil, ANVISA approved Naglazyme in just eight months based on a recent resolution that gives priority review for therapies that are developed for the treatment of neglected diseases or are considered orphan disorders.

This emphasizes the need to rapidly bring life-altering therapies to patients around the world, and we remain dedicated to pursuing continued geographic expansion and are optimistic regarding the long-term potential of Naglazyme.

BioMarin develops and commercializes biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme (galsulfase); Aldurazyme (laronidase); and Kuvan (sapropterin dihydrochloride) tablets.