10 июл. 2024 г. · LYFGENIA is indicated for treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events ...

8 дек. 2023 г. · The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years ...

LYFGENIA is a one-time gene therapy to treat sickle cell disease in individuals 12 years of age or older and a history of vaso-occlusive events (VOEs).

8 дек. 2023 г. · LYFGENIA is a one-time ex-vivo lentiviral vector gene therapy approved for the treatment of patients 12 years of age or older with sickle cell ...

8 дек. 2023 г. · The effective approval date will remain December 08, 2023, the date of the original approval letter. Please refer to your Biologics License ...

19 дек. 2023 г. · FDA approval history for Lyfgenia (lovotibeglogene autotemcel) used to treat Sickle Cell Disease. Supplied by Bluebird Bio, Inc.

19 дек. 2023 г. · The FDA's approval of the cell-based gene therapies, LYFGENIA and CASGEVY, shows promise for patients with sickle cell disease.

8 дек. 2023 г. · The recommendation for approval is based on demonstration of complete resolution of VOEs (VOE-CR) between 6-18 months in patients 12 years of ...

19 дек. 2023 г. · The Food and Drug Administration (FDA) approved two gene therapies for SCD, one of which is the first approved medication that uses the gene-editing tool ...

Find answers to frequently asked questions about LYFGENIA, an FDA approved gene therapy for sickle cell disease. Please see Important Safety Information, ...