European Commission Delays Decision on Glybera Marketing Authorisation
January 30, 2012 – Amsterdam Molecular Therapeutics (AMT), a leader in the field of human gene therapy, was informed on Friday January 27, 2012 after business hours that the European Commission’s Standing Committee discussed on Monday January 22, 2012 the implementation decision not to grant marketing authorization for Glybera (alipogene tiparvovec) as recommended by the Committee for Human Medicinal Products (CHMP).
After the discussion no clear position in favor or against granting a marketing authorization for Glybera was reached. Instead the Standing Committee considered it necessary to request additional information to the CHMP in the European Medicines Agency (EMA). A formal vote by the Standing Committee will be made on review of the additional information. It is currently unclear when a final decision will be reached.
