Zynteglo (betibeglogene autotemcel)
PRIMEATMPConditionalAccelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- betibeglogene autotemcel
- Company
- bluebird bio (Netherlands) B.V.
- Status
- Withdrawn
- Therapeutic area
- beta-Thalassemia
- CHMP opinion
- Thu 28 Mar 2019
- EU approval
- Wed 29 May 2019
- Designations
- PRIME, ATMP, Conditional, Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/003691
- ATC
- B06A
- Official record
- www.ema.europa.eu
Indication
Zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.