Data updated: Sep 20, 2026
Casgevy (exagamglogene autotemcel) · Vertex Pharmaceuticals
Approved 2023-12-07
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-12-07
- Patent Cliff
- 2031
- Revenue
- $76.4M (Q2-2026)
- Routes
- Intravenous
- Dosage Forms
- Suspension
Casgevy Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Dec 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What Casgevy Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2023)
Vertex Pharmaceuticals's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Casgevy FDA Label Details
Pro Intelligence Preview
Deep insights for Casgevy
Revenue Insights
- • Q2-2026: $76.4M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.