Drugs / Efanesoctocog alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Altuvoct | — | 2024-06-17 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05042440 | Aug → Nov 2021 | hemophilia A | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04770935 | May 2021 → Dec 2022 | von Willebrand disease (hereditary or acquired) | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03205163 | Aug 2017 → Nov 2018 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06716814 | Mar 2025 → Mar 2027 expected | hemophilia A | Swedish Orphan Biovitrum | Recruiting | No outcome recorded |
| Phase 3 | NCT05817812 | Jul 2023 → Jun 2026 | severe hemophilia A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Phase 3 | NCT04644575 | Feb 2021 → Jan 2027 expected | hemophilia A | Bioverativ, a Sanofi company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04759131 | Feb 2021 → Jan 2023 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 3 | NCT04161495 | Nov 2019 → Feb 2022 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06941870 | Sep 2025 → Oct 2027 expected | coagulation protein disease | Sanofi | Recruiting | No outcome recorded |
| Phase 4 | NCT06940830 | May 2025 → Dec 2028 expected | hemophilia A | Swedish Orphan Biovitrum | Recruiting | No outcome recorded |
| Phase 4 | NCT06752850 | Dec 2024 → Nov 2026 expected | hemophilia A | Swedish Orphan Biovitrum | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06579144 Comparator | Feb 2025 → May 2026 | hemophilia A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-17 | Sanofi | Press Release: NEJM publishes ALTUVIIIO XTEND-Kids phase 3 data supporting its potential to transform the treatment landscape for children with severe hemophilia A sanofi.com ↗ |
| 2024-06-21 | Sanofi | Press Release: ISTH: Sanofi advances leadership in hemophilia with new data for ALTUVIIIO and fitusiran sanofi.com ↗ |
| 2023-10-27 | Sanofi | Press Release: Specialty Care growth, strong launch uptake of Beyfortus® and ALTUVIIIO® drive solid Q3 results sanofi.com ↗ |
| 2023-09-25 | Sanofi | Press Release: Once-weekly ALTUVIIIO® approved in Japan as a new class of factor VIII therapy for hemophilia A sanofi.com ↗ |
| 2023-06-25 | Sanofi | Press Release: ALTUVIIIO® late-breaking data at ISTH demonstrates highly effective bleed protection in children with severe hemophilia A with once-weekly dosing sanofi.com ↗ |
| 2023-02-23 | Sanofi | Press Release: FDA approves once-weekly ALTUVIIIO™, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection sanofi.com ↗ |
| 2023-01-25 | Sanofi | Press Release: NEJM publishes once-weekly efanesoctocog alfa Phase 3 data demonstrating its potential to transform the treatment landscape for people with hemophilia A sanofi.com ↗ |
| 2022-08-30 | Sanofi | Press Release: FDA grants priority review to efanesoctocog alfa for people with hemophilia A sanofi.com ↗ |
| 2022-07-10 | Sanofi | Press Release: Pivotal data demonstrate once-weekly efanesoctocog alfa provides superior bleed protection compared to prior factor prophylaxis sanofi.com ↗ |
| 2022-06-01 | Sanofi | Press Release: FDA grants efanesoctocog alfa Breakthrough Therapy designation for hemophilia A sanofi.com ↗ |
| 2022-03-09 | Sanofi | Press Release: Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment sanofi.com ↗ |
| 2021-02-18 | Sanofi | Efanesoctocog alfa granted FDA Fast Track Designation for treatment of hemophilia A sanofi.com ↗ |
| 2020-09-10 | Sanofi | New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A sanofi.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efanesoctocog alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06579144 ↗ |
| Known as | Altuviiio | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095275 ↗ |
| Known as | Altuvoct | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095275 ↗ |
| Known as | BIVV001 | “Drug: efanesoctocog alfa (BIVV001)” NCT04759131 ↗4“efanesoctocog alfa (BIVV001)” NCT04644575 ↗ “efanesoctocog alfa (BIVV001)” NCT04161495 ↗ “efanesoctocog alfa (BIVV001)” NCT04770935 ↗ |
| Known as | Efanesoctocog alfa-ehtl | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095275 ↗ |
| Known as | rFVIIIFc-VWF-XTEN | “BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels.” PMID 32905674 ↗ Sep 20202“Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001)” NCT04759131 ↗ “Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001)” NCT04161495 ↗ |
| Action | Restore | “BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A.” PMID 32905674 ↗ Sep 2020 |
| Modality | Protein / enzyme biologic | “BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein” PMID 32905674 ↗ Sep 2020 |
| Route | Intravenous | “The patients then received a single intravenous injection of BIVV001 at the same corresponding dose of either 25 IU or 65 IU per kilogram.” PMID 32905674 ↗ Sep 2020 |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL5095275 ↗ |