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- CASGEVY | FDA - U. S. Food and Drug Administration
CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs)
- Casgevy FDA Approval History - Drugs. com
Casgevy was approved for use in the treatment of transfusion-dependent beta thalassemia on January 16, 2024 Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances FDA approval history for Casgevy (exagamglogene autotemcel) used to treat Beta Thalassemia, Sickle Cell Disease
- Vertex Announces US FDA Approval of CASGEVY™ (exagamglogene autotemcel . . .
BOSTON -- (BUSINESS WIRE)--Jan 16, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U S Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years a
- Search Orphan Drug Designations and Approvals - Food and Drug . . .
Casgevy Date Designated: 05 11 2020 Orphan Designation: Treatment of sickle cell disease Orphan Designation Status: Designated Approved Sponsor: Vertex Pharmaceuticals Inc 50 Northern
- Revolutionary breakthrough: FDA approves CASGEVY, the first CRISPR Cas9 . . .
Recently, Casgevy, the first CRISPR Cas9-based gene therapy for SCD, has received breakthrough FDA approval Clinical trials have shown that Casgevy administered to patients aged older than or equal to 12 years enables precise modifications in hematopoietic stem cells, resulting in elevated fetal hemoglobin (HbF) levels and a significant
- 两款基因编辑疗法在美获批 - 新浪财经
根据FDA公布的数据，支持Casgevy上市的试验主要终点是24个月的随访期内至少连续12个月无严重VOC发作，最终93 5%的患者达到了上述结果；评估Lyfgenia
- Vertex, CRISPRs Casgevy gets FDA nod for beta thalassemia
The approval for TDT, a rare blood disorder that leads to chronic anemia, comes far ahead of the FDA's PDUFA target action date of March 30, 2024 Casgevy notched its first U S approval back on December 8, when it became the first gene-edited cell therapy to treat patients with sickle cell disease
- A new frontier: FDA approvals for gene therapy in sickle cell disease
On December 8, 2023, the US Food and Drug Administration (FDA) approved two autologous gene therapy products, Lyfgenia (lovotibeglogene autotemcel by bluebird bio) and Casgevy (exagamglogene autotemcel by Vertex Pharmaceuticals), for the treatment of individuals with sickle cell disease (SCD) ages 12 years and older with recurrent vaso
- FDA Approves First Gene Therapies to Treat Patients with Sickle Cell . . .
Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises Casgevy is the first
- Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY . . .
Vertex has submitted a BLA to the U S FDA for the potential use of CASGEVY for patients 12 years and older with TDT and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 30, 2024 Vertex leads global development, manufacturing and commercialization of CASGEVY with support from CRISPR Therapeutics
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