www.fdanews.com/articles/80944-biomarin-s-naglazyme-gets-positive-opinion-from-chmp-for-eu-marketing-approval
BIOMARIN'S NAGLAZYME GETS POSITIVE OPINION FROM CHMP FOR EU MARKETING APPROVAL
September 16, 2005
BioMarin Pharmaceutical Inc said it has received a positive opinion from the EU's Committee for Medicinal Products for Human Use (CHMP) recommending that the EU Commission grant marketing authorisation for Naglazyme, a therapy for Maroteaux-Lamy syndrome, a rare genetic disease. CHMP's opinion will be forwarded to the EU Commission, which is expected to make a formal decision on marketing authorization within three to four months, BioMarin said late yesterday.
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