Endgame: Glybera finally recommended for approval as the first gene therapy drug in the European union

Molecular Therapy

Volumn 20, Issue 10, 2012, Pages 1831-1832

  Ylä Herttuala, Seppo ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALIPOGENE TIPARVOVEC; LIPOPROTEIN LIPASE; PARVOVIRUS VECTOR;

DISEASE SEVERITY; DRUG APPROVAL; DRUG INDICATION; DRUG MARKETING; EDITORIAL; EUROPEAN UNION; GENETIC ENGINEERING; HUMAN; HYPERLIPOPROTEINEMIA TYPE 1; MEDICAL DECISION MAKING; PANCREATITIS; PROTEIN EXPRESSION; VIRAL GENE THERAPY;

DEPENDOVIRUS; DRUG APPROVAL; EUROPEAN UNION; GENETIC THERAPY; GENETIC VECTORS; HUMANS; HYPERLIPOPROTEINEMIA TYPE I; LEGISLATION, DRUG; LIPOPROTEIN LIPASE;

EID: 84866899464     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/mt.2012.194     Document Type: Editorial

References (2)

1. Ylä-Herttuala, S (2012). The need for increased clarity and transparency in the regulatory pathway for gene medicines in the European Union. Mol Ther 20: 471-472.
2. European Medicines Agency. Press release: European Medicines Agency recommends frst gene therapy for approval 〈http://www.ema.europa.eu/ema/ index.jsp?curl=pages/news-and-events/news/2012/07/news-detail-001574. jsp&mid=WC0b01ac058004d5c1〉 (20 July 2012).