restando su una di questo tipo.. AMT
May 10, 2011
Company to Present Updated Glybera Biomarker Data at American Society of Gene and Cell Therapy Annual Meeting May 18-21
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, provided today a status update on Glybera (alipogene tiparvovec), its gene therapy product under development for the treatment of lipoprotein lipase deficiency (LPLD).
Following the submission of the Day 180 questions at the end of the first quarter to the European Medicines Agency (EMA) as part of Glybera’s Market Authorisation Application (MAA), AMT continues to work diligently with the EMA and is confident that a decision on the approval of Glybera remains on track for mid-2011 as previously guided.“Our interactions with the EMA continue to be positive and we are encouraged as we hit each milestone in the path towards a regulatory decision. If approved, Glybera would be the first gene therapy product to reach the market in Europe. We will continue to work with the EMA so that the review of our data remains on track as much as possible from our side and look forward to a decision in mid-2011,” stated Jörn Aldag, CEO of AMT. “Our data are key to supporting our MAA. Later this month we will present additional data at ASGCT regarding improved chylomicron handling, which we believe could be used in the future by physicians as a biomarker for Glybera in LPLD patients.”