6533b7d9fe1ef96bd126c253
RESEARCH PRODUCT
Regulatory evaluation of Glybera in Europe — two committees, one mission
Gopalan NarayananGiulio CossuLuca PaniPaolo GaspariniBrigitte NeugebauerJohn Joseph BorgPiotr FiedorJanis AncansJan Müller-berghausTomas SalmonsonJuris PokrotnieksIan HudsonIan HudsonDaniela MelchiorriCatherine DraiEgbert FloryHubert G. M. LeufkensChristian SchneiderJean Louis Robertsubject
Pharmacologymedicine.medical_specialtybusiness.industryGenetic TherapyGeneral MedicineMarketing authorizationBiotechnologyAlipogene tiparvovecHuman useFamily medicineDrug DiscoveryAgency (sociology)Drug approvalHumansMedicineWestern worldmedia_common.cataloged_instanceHyperlipoproteinemia Type IEuropean UnionCooperative behaviorCooperative BehaviorEuropean unionbusinessDrug Approvalmedia_commondescription
Representing the first gene therapy to be approved in the Western world, alipogene tiparvovec (Glybera; Uniqure) has recently been said to have had a “substantial impact from a regulatory perspective” (Nature Rev. Drug Discov. 11, 664; 2012) 1 . The therapy was granted marketing authorization in the European Union for the treatment of lipoprotein lipase deficiency, which results in a clinically heterogeneous condition with a risk of potentially life-threatening pancreatitis 2 , at the end of 2012. The decision followed a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) 3
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2013-01-01 | Nature Reviews Drug Discovery |