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news.The Netherlands-based Amsterdam Molecular Therapeutics (AMT) has filed a request to the European Medicines Agency (EMA) to re-examine its marketing authorisation application (MAA) for Glybera.
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AMT has developed Glybera for the treatment of patients who are suffering from genetic disorder lipoprotein lipase deficiency (LPLD).
The re-examination of the dossier is expected to be concluded by the end of 2011.
In a clinical trial, Glybera (alipogene tiparvovec) showed reduction in the the risk of pancreatitis in patients with LPLD.