ITVISMA Purple Book BLA 125856
- BLA number
- 125856
- Proprietary names
- ITVISMA
- Proper names
- onasemnogene abeparvovec-brve
- Applicant
- Novartis Gene Therapies, Inc.
- Center
- CBER
- First observed release
- 2025-12-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | ITVISMA | onasemnogene abeparvovec-brve | 351(a) | 4x10^13VG/ML | Injection | Intrathecal | Single-Dose Vial | Rx | Licensed | 2025-11-24 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2025-12-01 | N | 001 | ITVISMA | 351(a) | Rx | Novartis Gene Therapies, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-12-01 | 001 | ITVISMA | 351(a) | Rx | Licensed | 2025-11-24 |