Amsterdam Molecular Therapeutics (AMT), a leader in the field of human gene therapy, announced that it has filed a request for re-examination of the Marketing Authorisation Application for Glybera with the European Medicines Agency. Glybera is a gene therapy for the genetic disorder lipoprotein lipase deficiency. The company expects that the re-examination of the dossier will be completed by the end of 2011.
AMT is a world leader in the development of human gene based therapies. The company’s lead product Glybera, a gene therapy for lipoprotein lipase deficiency (LPLD), is currently under review by the European Medicines Agency (EMA). If approved, Glybera will be the first gene therapy product to be marketed in Europe.