Drugs / eptacog beta
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | hemophilia A with vascular abnormality | — | “The marketing authorization file has also been submitted to the UK authorities (MHRA) and the file is currently under review.” groupe-lfb.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07136857 | Oct 2025 → Dec 2026 expected | Glanzmann thrombasthenia | Emory University | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02020369 | Apr 2014 → Jul 2015 | hemophilia A, hemophilia B | rEVO Biologics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04647227 | Jun 2021 → Sep 2026 overdue | hemophilia A, hemophilia B | American Thrombosis and Hemostasis Network | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02448680 Comparator | Dec 2015 → Jun 2017 | hemophilia A, hemophilia B | LFB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-07-25 | Groupe Lfb | Regulatory LFB announces the approval of CEVENFACTA® (eptacog beta) in the European Union groupe-lfb.com ↗
LFB today announced that the European Medicines Agency (EMA) has granted on July 15th a Marketing Authorisation for CEVENFACTA® (eptacog beta), as the first new bypassing agent in over 20 years. |
| 2021-03-01 | Groupe Lfb | Regulatory LFB announces that the European Medicines Agency (EMA) has accepted for filing the Marketing Authorization Application for eptacog beta (activated), a recombinant coagulation Factor VIIa groupe-lfb.com ↗
LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa). |
| 2020-04-06 | Groupe Lfb | Regulatory LFB announces FDA approval of SEVENFACT®, a new recombinant coagulation Factor VIIa groupe-lfb.com ↗
LFB announces FDA approval of SEVENFACT®, a new recombinant coagulation Factor VIIa |
All press releases naming this drug 3 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EPTACOG BETA | “Eptacog beta is an activated recombinant human factor VII bypassing agent approved for treating bleeding episodes (BEs) in patients aged ≥12 years with haemophilia A or B with...” PMID 40674256 ↗ Jul 20253“Eptacog beta, a recombinant factor VIIa bypassing agent, has demonstrated safety and efficacy in the management of bleeding events (BEs) in people with hemophilia and inhibitors.” PMID 42382314 ↗ Apr 2026 “Eptacog beta is a recombinant activated human factor VII bypassing agent approved for treating and controlling bleeding in PwHABIs aged ≥12 years.” PMID 40765904 ↗ Mar 2025 |
| Known as | SEVENFACT | “Eptacog beta (SEVENFACT®; EB) is a lyophilized powder in single-use vials (1, 2, or 5 mg) of coagulation factor VIIa (recombinant)-jncw.” NCT07136857 ↗ |
| Modality | Protein / enzyme biologic | “Eptacog beta is a recombinant activated human factor VII bypassing agent approved for treating and controlling bleeding in PwHABIs aged ≥12 years.” PMID 40765904 ↗ Mar 2025 |
| Route | Intravenous | “reconstituted with sterile water (provided in the kit) and administered intravenously.” NCT07136857 ↗ |