Sevenfact (eptacog beta activated) / LFB SA, HEMA Biologics - LARVOL DELTA

In vitro comparison of eptacog beta and eptacog alfa with antithrombin lowering (simulated fitusiran) using thrombin generation assay (ASH 2025) - "These results demonstrate that in vitro both eptacog beta and eptacog alfa similarly increase TG when ATlevels are reduced to fitusiran target ranges. Eptacog alfa doses of 45µg/kg, used to treat bleeds inpatients on fitusiran, had similar TG parameters to the 75µg/kg and 125µg/kg doses of eptacog beta. Thisdata provides in vitro proof of concept supporting the use of eptacog beta for the treatment ofbreakthrough bleeds of patients on fitusiran prophylaxis."

Preclinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Real World Experience with use of Coagulation Factor VIIa at an Academic Medical Center. (PubMed, Clin Appl Thromb Hemost) - "Our institution converted from eptacog alfa to eptacog beta as the preferred rFVIIa product. Cost avoidance was estimated at $554,400 over a 12-month period.ConclusionWe treated a small cohort of patients with eptacog beta without adverse outcomes. Other hospitals might evaluate their rFVIIa use and consider opportunities for substitution."

Journal • Real-world evidence • Retrospective data • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • Thrombosis

Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531) (clinicaltrials.gov) - P2 | N=6 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

Real-World Experience with Eptacog Beta for On-Label and Off-Label Indications: The Spanish Experience. (PubMed, Pharmaceuticals (Basel)) - "Preclinical studies have shown the product has a similar profile to eptacog alfa. Our experience provides further evidence of the efficacy and safety of eptacog beta for surgical prophylaxis and treatment of bleeding in patients with haemophilia A with inhibitors, but also in those with factor VII deficiency. To our knowledge, this is the first report to describe the use of eptacog beta for factor VII deficiency and acquired haemophilia."

Journal • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Low Rebleed Incidence with Eptacog Beta Treatment through 24 and 48 Hours in Children (<12 years) with Hemophilia a or B with Inhibitors (ASH 2023) - P3 | "These findings align with those previously reported for PERSEPT 1 in adolescent and adult patients. Combined with the high efficacy at 24 hours (>96%) observed in both trials and both IDRs, these results suggest that eptacog beta can provide clinicians and caregivers with a treatment option that can establish and maintain hemostatic control of mild or moderate BEs in PwHABI of all ages."

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Pediatrics • Rare Diseases

Pain Reduction Following Treatment of Bleeding Episodes with Eptacog Beta in Adults and Adolescents with Hemophilia A or B Complicated By Inhibitors (ASH 2024) - P3 | "Our findings provide new benchmark measurements of clinically relevant pain relief in PwHABI. We propose that the reductions in pain observed in this study might be adopted as a possible endpoint for substantive effect when designing clinical trials of bypassing agents in PwHABI."

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Pain • Rare Diseases

Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531) (clinicaltrials.gov) - P2 | N=6 | Not yet recruiting | Sponsor: Emory University

New P2 trial • Hematological Disorders

Treatment of severe bleeds with eptacog beta in hemophilia A or B with inhibitors: a post hoc analysis of the PERSEPT 1 and 2 trials. (PubMed, Blood Vessel Thromb Hemost) - P3 | "Most severe BEs resolved with eptacog beta treatment during PERSEPT 1 and PERSEPT 2. The PERSEPT 1 and PERSEPT 2 trials were registered at www.clinicaltrials.gov as #NCT02020369 and #NCT02448680, respectively."

Journal • Retrospective data • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Safety and Use of Eptacog Beta 225 µg/kg in Patients With Haemophilia A or B With Inhibitors. (PubMed, Haemophilia) - P1, P3 | "These findings demonstrate favourable safety and tolerability regarding the use of the 225 µg/kg IDR."

Journal • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Immunology • Rare Diseases

Pain Reduction Following Eptacog Beta Treatment of Bleeding Episodes in Adolescents and Adults With Haemophilia A or B Complicated by Inhibitors. (PubMed, Haemophilia) - "Pain relief over 24 h was observed with eptacog beta treatment across IDR and age categories. This post hoc study demonstrates that percentage reduction from baseline VAS score influences perception of bleed resolution and can predict treatment outcomes."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Pain • Rare Diseases

Recombinant factor VIIa: new insights into the mechanism of action through product innovation. (PubMed, Res Pract Thromb Haemost) - "Eptacog alfa and eptacog beta share the same amino acid sequence but differ in posttranslational modifications. Further research is required to assess the clinical relevance of these differences. A better understanding of the mechanisms by which rFVIIa promotes hemostasis in patients will provide insights when evaluating clinical outcomes of safety and efficacy for innovative bypassing therapies."

Journal • Review • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • PROCR

Real-World Effectiveness of Eptacog Beta [Coagulation Factor VIIa (Recombinant)] in the USA (EAHAD 2025) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence

Bleed treatment with eptacog beta (rFVIIa) results in a low incidence of rebleeding in adult and adolescent patients with haemophilia A or B with inhibitors. (PubMed, Haemophilia) - "Subjects with haemophilia with inhibitors who used eptacog beta to treat mild/moderate BEs experienced a low incidence of rebleeding. Rebleeds that did occur were effectively controlled with eptacog beta (median, one dose) without the need for hospitalization."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

ATHN 16: SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (clinicaltrials.gov) - P4 | N=55 | Recruiting | Sponsor: American Thrombosis and Hemostasis Network | Trial completion date: Jun 2025 ➔ Mar 2027 | Trial primary completion date: Nov 2024 ➔ Sep 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Real-world effectiveness of eptacog beta in patients with haemophilia and inhibitors: A multi-institutional case series. (PubMed, Haemophilia) - "In this case series, eptacog beta was safe, effective, and economical as first-line therapy, treatment of refractory BEs, management of perioperative bleeding, or prophylaxis in haemophilia patients with inhibitors."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Osteoarthritis • Rare Diseases

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® (clinicaltrials.gov) - P=N/A | N=17 | Completed | Sponsor: Laboratoire français de Fractionnement et de Biotechnologies | Recruiting ➔ Completed

Real-world • Real-world evidence • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

High Bleed Control with a Single 225 µg/kg Eptacog Beta Dose in Adult and Adolescent Hemophilia A or B Persons with Inhibitors (ISTH 2024) - P3 | "Twenty-five out of 27 subjects treated 213 mild/moderate BEs using the 225µg/kg IDR, and a single-dose efficacy of 84% was observed. Single-dose efficacy with the 225µg/kg IDR for 182 joint and 31 non-joint BEs was 86.5% and 72.4%, respectively. Similar single-dose efficacy was observed for 58 target joint and 124 non-target joint BEs (84.6% and 87.3%, respectively) and for 182 spontaneous and 31 traumatic BEs (85.8% and 76.7%, respectively; Figure 2)."

Clinical • Hematological Disorders • Hemophilia • Rare Diseases

EFFICACY AND SAFETY OF EPTACOG BETA FOR BLEED TREATMENT IN ADULTS AND ADOLESCENTS WITH HEMOPHILIA B AND INHIBITORS DURING PERSEPT 1 (THSNA 2024) - "While assigned to the 225µg/kg IDR, Subject 1 experienced a treatment-related adverse event (increased body temperature) of moderate severity, which resolved following administration of ibuprofen and other non-steroidal anti-inflammatory medications.  Both eptacog beta IDRs provided safe and effective control of mild or moderate BEs in PwHBI during PERSEPT 1. Most BEs experienced by PwHBI were successfully treated at 12 h post-initial eptacog beta infusion, and all BEs in PwHBI treated with the 225µg/kg IDR had resolved at 24 h. These results support the efficacy and safety of eptacog beta for BE treatment in adult and adolescent PwHBI."

Clinical • Hematological Disorders • Hemophilia • Immunology • Pain • Rare Diseases

INSIGHT INTO ATHN 16: TREATMENT OF BLEEDING EVENTS IN PATIENTS WITH CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS TO EVALUATE THE SAFETY OF COAGULATION FACTOR VIIA (RECOMBINANT)-JNCW (THSNA 2024) - P4 | "All study participants with severe hemophilia received prophylactic emicizumab with one starting emicizumab prophylaxis during the trial. To date, the safety profile of eptacog beta for the treatment of BEs in the ATHN 16 participants is consistent with previously published reports."

Clinical • Cardiovascular • Hematological Disorders • Hemophilia • Infectious Disease • Oncology • Rare Diseases • Thrombosis

REBLEED INCIDENCE WITH EPTACOG BETA TREATMENT THROUGH 24 AND 48 HOURS IN CHILDREN (UNDER 12 YEARS) WITH HEMOPHILIA A OR B WITH INHIBITORS (THSNA 2024) - P3 | "BE treatment using either eptacog beta IDR led to low rebleeding incidence (<3%) through 24 and 48 hours in PwHABI <12 years during PERSEPT2."

Clinical • Hematological Disorders • Hemophilia • Pain • Pediatrics • Rare Diseases

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Laboratoire français de Fractionnement et de Biotechnologies | Trial primary completion date: Jan 2024 ➔ Apr 2024

Real-world • Real-world evidence • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

Eptacog beta for the management of patients with haemophilia A and B with inhibitors: A European perspective. (PubMed, Haemophilia) - "In this review, we summarise current data regarding the mode of action, clinical efficacy and safety of eptacog beta for the management of haemophilia A and B in patients with inhibitors from a European perspective. In addition to providing a valuable summary of the analyses of the clinical data for eptacog beta conducted for the EMA, our review summarises the potential differentiators for eptacog beta compared with other current bypassing agents."

Journal • Review • Hematological Disorders • Hemophilia • Rare Diseases

Stability of Eptacog Beta After Reconstitution (EAHAD 2024) - No abstract available

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Laboratoire français de Fractionnement et de Biotechnologies | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

Race against time: Evaluating eptacog beta for bleeding cessation in pediatric patients (ASHP 2023) - No abstract available

Clinical • Pediatrics