News spread like wildfire on Friday, July 20th, when the first gene therapy product was recommended for approval by the European Medicines Agency’s Committee for Medinical Products for Human Use (CHMP). The gene therapy in question, Glybera, is for lipoprotein lipase deficiency (LPLD), a rare familial condition that is characterized by massive chylomicronemia (inability to breakdown lipids correctly) and decreased levels of other lipoproteins. Based on the rarity of the disease, seeking official approval has been an uphill battle and ultimately ended in defeat for the original developers of the therapy, Amsterdam Molecular Therapeutics (AMT), who were forced to close their doors. Fortunately, however, their assets were passed on to uniQure in early April and they have valiantly picked up the fight with a possible win in reach. With only one more decision standing in their way, that of the European Commission, they could be the first to produce a gene therapy product sanctioned for use in Europe and the US. Up until now, real world application of gene therapy has been a pipe dream of both doctors and patients alike, despite the fact that ongoing research has proven its potential time and time again in both preclinical and human-based trials. Have we finally reached the turning point in regulatory thinking? Not only would this be a revolutionary decision by the European Commission should they choose to accept the recommendation by the CHMP, but this could change the face of medicine forever. Imagine a world where diseases were no longer simply treated with pain and symptom management, but could be cured for good. With new and improved delivery techniques becoming available, patients across the world suffering from previously “incurable” diseases could walk away with a clean bill of health. If Glybera is approved, we can only hope that more are on their way.