G-BA suspends Glybera assessment pending EMA decision

The German reimbursement agency G-BA suspended its benefit assessment of gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE). The move followed uniQure's disclosure in an SEC filing that on April 8 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 for Glybera to treat the Orphan disease lipoprotein lipase deficiency (LPLD). ...