According to a BioSpace report, the European Commission (EC) has delayed its decision to grant marketing authorisation for gene therapy with alipogene tiparvovec (Glybera™) in patients with lipoprotein lipase deficiency, as recommended by the Committee for Human Medicinal Products (CHMP).

Further information was requested from the CHMP and a formal vote by the European Parliament's Standing Committee will be made on review of this additional information. It is currently unclear when a final decision will be reached.

The CHMP adopted a negative opinion in June 2011 on the basis of insufficient evidence of the benefits and safety of Glybera (see NELM abstract below for further details).

Glybera has been granted orphan drug status in the EU and US.