Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia

Clin Pharmacol Ther. 2020 Mar;107(3):492-494. doi: 10.1002/cpt.1639. Epub 2019 Nov 8.

Authors

Martina Schuessler-Lenz¹, Harald Enzmann², Spiros Vamvakas³

Affiliations

¹ European Medicines Agency (EMA) Committee for Advanced Therapies, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
² European Medicines Agency (EMA) Committee for Human Medicinal Products, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany.
³ Product Development Scientific Support Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.

No abstract available

MeSH terms

Drug Approval
Europe
Genetic Therapy / legislation & jurisprudence*
Government Agencies*
Humans
Technology Assessment, Biomedical / legislation & jurisprudence*
beta-Thalassemia / genetics
beta-Thalassemia / therapy*