uniQure, Chiesi sales and marketing update

Germany’s Federal Joint Committee (G-BA) suspended assessment of Glybera alipogene tiparvovec from uniQure after it received a rapporteur’s assessment report from EMA’s Committee for Advanced Therapy Medicinal Products (CAT) that said Glybera lacked efficacy and therefore had a negative benefit-risk balance. The rapporteur’s report is under review at the CAT’s monthly meeting, where the committee is considering uniQure’s Type II variation application to add six-year follow-up data to the label of Glybera to treat the Orphan disease lipoprotein lipase deficiency (LPLD). G-BA now expects to make a decision by May 7. ...