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news.Amsterdam Molecular Therapeutics (AMT) has announced that the submission of its Glybera Marketing Authorisation Application (MAA) has cleared the validation stage with the European Medicines Agency (EMA). Glybera is the company's proprietary product for lipoprotein lipase deficiency (LPLD). The EMA will now commence its formal review of Glybera.
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AMT has concluded two clinical studies for LPLD in Europe and Canada. Long term follow-up from both of these is ongoing, as is a third clinical study in Canada. In these three studies, Glybera has shown a decrease in the incidence of pancreatitis, or acute inflammation of the pancreas in LPLD patients. In addition, these studies indicate Glybera’s safety profile.
Jorn Aldag, chief executive officer of AMT, said: “The acceptance of the Glybera dossier by EMA is a significant step towards marketing approval for Glybera. Moreover, it demonstrates AMT’s development capability. A future approval of the MAA for Glybera would fully validate our gene therapy approach and our adeno-associated viral (AAV) vector delivery platform. We believe this step offers hope to many patients, as gene therapy may become the therapeutic approach of choice for inherited disorders.”
During 2010, AMT expects to provide further updates on the results from its follow-up and ongoing studies, in accordance with reporting regulations.