EMA Starts Formal Review of LPLD Drug
- Posted on 28 January 2010
Amsterdam Molecular Therapeutics has reached another milestone in the official marketing authorization process for its lead product Glybera, for Lipoprotein Lipase Deficiency (LPLD).
The submission of the Marketing Authorisation Application (MAA), has cleared the validation stage with The European Medicines Agency (EMA, formerly known as EMEA). The EMA will now commence its formal review.
AMT has concluded two clinical studies for LPLD, in Europe and Canada, and 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 sizeable decrease in the incidence of pancreatitis, or acute inflammation of the pancreas, the most debilitating complication of LPLD.
