Altuviiio
efanesoctocog alfa
APPROVED
Drug Profile
ModalityRecombinant protein
RouteIV
Therapy AreaHematology
Launch2023-02-22
Peak Sales Est$3000M
Formulations[{"id":"altuviiio-iv","doses":"50 IU/kg once weekly","route":"IV","device":"Reconstitution kit with
Companies
SAN (ORIGINATOR)100%
Mechanism: Extended half-life recombinant Factor VIII
Expert: Recombinant FVIII-Fc fusion protein with XTEN polypeptide technology (efanesoctocog alfa). Single-chain design with enhanced VWF interaction provides 3-4x extended half-life compared to standard rFVIII. Achieves sustained near-normal FVIII activity levels with once-weekly IV dosing.
Everyday: A longer-lasting version of the missing clotting factor itself. Normal Factor VIII replacement needs injection every 2-3 days because it gets cleared from blood quickly. This version is engineered to last longer (Fc fusion + XTEN technology), so patients only need a weekly infusion instead.
Targets: []
Revenue History
| Period | Revenue ($M) |
|---|
| 2023 | $171M |
| 2024 | $702M |
Programs (1)
| Indication | Stage | Key Study | Regional Status |
|---|
| Hem A without inhibitors | APPROVED | XTEND-1 | [{"stage":"APPROVED","region":"US","approval_date":"2023-02-22"}] |
Upcoming Catalysts (1)
Altuviiio - Hemophilia A Commercial Ramp (EU/Middle East)
Quarterly through 2026-2027
Notes
Extended half-life rFVIII. 3-4x longer half-life via Fc fusion + XTEN tech. Weekly IV achieves near-normal FVIII levels. $702M in 2024 (rapid ramp). For patients preferring actual factor replacement. Key differentiator: normalizes FVIII levels (relevant for surgery, trauma) vs nonfactor therapies.
DUAL BRANDING: Marketed as Altuviiio by Sanofi (US) and Altuvoct by SOBI (ex-US). Same drug (efanesoctocog alfa). SOBI ex-US revenue: SEK 1,023M in Q4 2025 (vs SEK 302M prior year Q4) — rapid launch ramp.
Data from Supabase · Updated 2026-03-24