uniQure, Chiesi sales and marketing update

EMA’s Committee for Advanced Therapies (CAT) said it did not agree with a rapporteur’s preliminary assessment report for Glybera alipogene tiparvovec from uniQure that said Glybera lacked efficacy and therefore had a negative benefit-risk balance. The committee said Glyvera’s efficacy “needs to be considered in totality.” CAT will continue to evaluate the six-year follow-up data and asked for supplemental information from the company.

Germany’s Federal Joint Committee (G-BA) suspended assessment of Glybera until May 7 after receiving the rapporteur’s assessment. The committee now expects to make a decision by May 21 (see BioCentury, April 27). ...