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news.Amsterdam Molecular Therapeutic's (AMT) marketing authorisation application (MAA) for Glybera has received negative opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
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Glybera is used to treat patients with the genetic disorder lipoprotein lipase deficiency (LPLD).
AMT CEO Jorn Aldag said they believe that there is an indication from the CHMP that Glybera could receive approval and that the current opinion at this time is a reflection of insufficient proof of clinical benefit of Glybera as a result of low patient numbers measured for chylomicron handling for at least 12 months post treatment.
"The CHMP also indicated that if certain additional data from already treated patients would confirm current results by the end of 2011, an approval may be possible," Aldag said.
"While we pursue the re-examination of Glybera, we will also continue development of other products such as hemophilia B and GDNF gene therapy for Parkinson’s disease and Huntington’s disease."