Amsterdam Molecular Therapeutics B.V
EMA Starts Formal Review of Glybera Dossier
Published in Genetics and Environmental Business Week, February 11th, 2010
the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera®, AMT's proprietary product for lipoprotein lipase deficiency (LPLD). The submission of the Glybera® Marketing Authorisation Application (MAA), announced earlier, has cleared the validation stage with The European Medicines Agency (EMA, formerly known as EMEA). The EMA will now commence its formal review of Glybera®.
AMT has concluded two clinical studies for LPLD, in Europe and Canada, and long term follow-up from both of...
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