FDA approved the original biologics license application for LAMZEDE on February 16, 2023, sponsored by CHIESI FARMACEUTICI SPA. FDA classed that submission a new molecular entity, which makes it the first approval of velmanase alfa-tycv in any product. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761278
- Sponsor
- CHIESI FARMACEUTICI SPA
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- velmanase alfa-tycv
Browse every approval whose brand starts with L, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| velmanase alfa-tycv 10MG | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | — | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to CHIESI FARMACEUTICI SPA
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