Efanesoctocog alfa
As of the edition of 20 October 2026, Efanesoctocog alfa is a protein: marketed, first approved in 2023 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Protein
- Brand name
- Altuviiio
- First approved
- 22 February 2023 (US)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- Swedish Orphan Biovitrum; 3 holders in all
- Registered trials
- 15, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Bones, joints and muscles; Cancer; Immune system
US protection
US protection ends in 2035.
US protection ends in 2035, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Bioverativ Therapeutics. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 3 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 5 | 3 | 2 | 0 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 2017 to now |
| Swedish Orphan Biovitrum | Applicant and Lead sponsor of trials | 2023 to now |