Lenmeldy Purple Book BLA 125758
- BLA number
- 125758
- Proprietary names
- Lenmeldy
- Proper names
- atidarsagene autotemcel
- Applicant
- Orchard Therapeutics (Europe) Ltd.
- Center
- CBER
- First observed release
- 2024-03-01
- 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 | Lenmeldy | atidarsagene autotemcel | 351(a) | 2 x 10^6 to 11.8 x 10^6CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | 2024-03-18 | |
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 |
|---|
| 2024-04-01 | U | 001 | Lenmeldy | 351(a) | Rx | Orchard Therapeutics (Europe) Ltd. |
| 2024-03-01 | N | 001 | Lenmeldy | 351(a) | Rx | Orchard Therapeutics (Europe) Ltd. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-03-01 | 001 | Lenmeldy | 351(a) | Rx | Licensed | 2024-03-18 |