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G-BA postpones Glybera assessment

May 8, 2015 2:17 AM UTC

Germany's Federal Joint Committee (G-BA) postponed until May 21 its expected decision on a benefit assessment of gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE). The committee did not provide a reason for the delay.

G-BA previously expected to issue a decision Thursday, pending decisions by EMA's Committee for Advanced Therapy Medicinal Products (CAT) and CHMP regarding 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) (see BioCentury Extra, April 17). ...