Drugs / rFVIIIFc
rFVIIIFc
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | ELOCTA | hemophilia B leyden | 2014-10-31 | “today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) of Elocta((TM)) (rFVIIIFc)” sobi.com ↗ “today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) of ELOCTA ™ (rFVIIIFc)” biogen.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02083965 | Mar → Oct 2014 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01027377 | Dec 2009 → Jul 2010 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT06137092 | Jul → Sep 2023 | severe hemophilia A | AryoGen Pharmed Co. | Completed | Met primary |
| Phase 3 | NCT02502149 | Aug 2015 → Apr 2017 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02234323 | Jan 2015 → Sep 2019 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 3 | NCT01458106 | Nov 2012 → Dec 2013 | hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01454739 | Dec 2011 → Oct 2017 | hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01181128 | Nov 2010 → Aug 2012 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03093480 | Dec 2017 → May 2020 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2025-09-22 | Beijing Tiantan Biological Products Co., Ltd. | Results 长效革新· 生命续航——国药天坛蓉生“注射用重组人凝血因子Ⅷ-Fc融合蛋白”开启“长效纪元”，重塑血友病A治疗新模式 tiantanbio.com ↗
Ⅰ期临床数据显示，不良反应发生率低，常见不良反应类型符合国外同类产品说明书已发布不良反应类型。 |
| 2022-07-13 | Sobi, Inc. | Results New real-world data shows significantly improved prophylactic effectiveness in patients treated with Elocta compared with standard half-life factor VIII sobi.com ↗
New real-world data shows significantly improved prophylactic effectiveness in patients treated with Elocta compared with standard half-life factor VIII |
| 2022-06-24 | Sobi, Inc. | Results Sobi to present new data at ISTH 2022 sobi.com ↗
Recombinant factor VIII Fc showed better prophylactic effectiveness compared to standard half-life factor VIII in haemophilia A - results from A-SURE, a 24-month prospective, non-interventional study |
| 2021-03-26 | Sobi, Inc. | Results Evaluation of haemophilia A treatment options shows favourable efficacy results for Elocta® sobi.com ↗
The publication reported in an indirect comparison that individualised prophylaxis with Elocta® (rFVIIIFc-efmoroctog alfa) is more efficacious than Hemlibra™ (emicizumab) administered every four weeks, and at least as effective as more frequent emicizumab regimens for the management of haemophilia A. |
| 2021-02-18 | Sanofi | Regulatory Efanesoctocog alfa granted FDA Fast Track Designation for treatment of hemophilia A sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for efanesoctocog alfa, previously known as BIVV001 (rFVIIIFc-VWF-XTEN), in patients with hemophilia A. |
| 2021-01-26 | Sobi, Inc. | Results Favourable results for Elocta® when evaluating treatment options for haemophilia A sobi.com ↗
The journal reported that when using individualised prophylaxis with extended half-life (EHL) products, Elocta® (rFVIIIFc) resulted in lower annual bleed rates when compared to Jivi™ (BAY 94-9027). |
| 2020-07-13 | Sobi, Inc. | Results Data presented at ISTH2020 strengthens evidence for both Elocta ® and Alprolix ® in previously untreated patients with haemophilia sobi.com ↗
Data demonstrates that Elocta was well tolerated and effective in this paediatric patient population. |
| 2019-07-09 | Sobi, Inc. | Results Switching to extended half-life prophylaxis impacted clinical outcomes and improved quality of life for people with haemophilia A or B sobi.com ↗
Clinical study data on switching haemophilia A and B patients from on-demand treatment to extended half-life (EHL) prophylaxis showed a positive impact on clinical outcomes, with improvements in quality of life (QoL) and reduced annual bleeding rates (ABR). |
| 2019-07-08 | Sobi, Inc. | Results Interim data evaluating Elocta® for Immune Tolerance Induction in people with inhibitors and severe haemophilia A shared at ISTH 2019 sobi.com ↗
Interim results from verITI-8, an ongoing prospective, phase 4 study evaluating the efficacy of Elocta® (efmoroctocog alfa), for first-time Immune Tolerance Induction (ITI) for people with severe haemophilia A with inhibitors were presented today. |
| 2019-05-10 | Sobi, Inc. | Results Individualised extended half-life factor replacement therapy controls haemostasis in orthopaedic surgery sobi.com ↗
Most major procedures required one injection to maintain haemostasis during surgery, and all haemostatic responses were assessed as excellent or good by the investigator/surgeon. |
| 2018-12-01 | Sobi, Inc. | Results At ASH, extended half-life therapies Elocta® and Alprolix® demonstrate proven efficacy and well-characterised safety over four years sobi.com ↗
ASPIRE and B-YOND extension studies show no inhibitor development and consistently low annualised bleeding rates in study participants over four years with Elocta and Alprolix, respectively. |
| 2018-02-07 | Sobi, Inc. | Results Time to elevate protection in haemophilia care: New data from Sobi™ sobi.com ↗
The data, gathered from the UK National Haemophilia Database, demonstrates a significant reduction of injection frequency and clotting factor consumption |
| 2017-12-10 | Sobi, Inc. | Results Study shows weekly prophylactic treatment with Elocta® resulted in bleed protection and target joint resolution in people with haemophilia A sobi.com ↗
This new, post-hoc analysis supports a growing body of clinical data showing prophylactic treatment with Elocta can positively impact long-term joint health. |
| 2017-10-31 | Sobi, Inc. | Results Interim data published in Haemophilia show improvements in long-term joint health for haemophilia A patients after prophylactic treatment with Elocta® sobi.com ↗
Interim data show participants enrolled in the ASPIRE extension study demonstrated continuous improvement in joint health over a nearly three-year period with prophylactic dosing of Elocta/ELOCTATE, regardless of prior treatment regimen, severity of joint damage or target joints. |
| 2017-05-18 | Sobi, Inc. | Regulatory Elocta® approved in the Kingdom of Saudi Arabia for the treatment of haemophilia A sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Elocta® (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A. |
| 2017-03-02 | Sobi, Inc. | Regulatory Sobi™ receives approval from the European Medicines Agency for higher capacity drug substance manufacturing for Elocta® sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta® (efmoroctocog alfa). |
| 2016-11-21 | Sobi, Inc. | Regulatory Elocta® approved in Kuwait for the treatment of haemophilia A sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Ministry of Health in Kuwait has approved Elocta® (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A. |
| 2016-09-23 | Sobi, Inc. | Regulatory Elocta® obtains national reimbursement in Spain, now available in the five largest markets in the EU sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the company’s product Elocta® (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life for the treatment of haemophilia A, has received national reimbursement approval in Spain. |
| 2016-09-21 | Sobi, Inc. | Regulatory Elocta® obtains reimbursement in UK, Italy and France, complemented by real-world data and extensive patient experience sobi.com ↗ |
| 2016-06-27 | Sobi, Inc. | Regulatory Sobi's Elocta® (rFVIIIFc) approved in Switzerland for the treatment of haemophilia A sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A. |
| 2016-03-24 | Sobi, Inc. | Regulatory European Commission approves transfer of marketing authorisation for Elocta® to Sobi sobi.com ↗ |
| 2016-01-28 | Sobi, Inc. | Results Sobi™ to present new interim ASPIRE data at EAHAD congress suggesting that patients can reduce bleeding rates with long-term Elocta® treatment sobi.com ↗
“The interim data from our long-term Elocta extension study, ASPIRE, show that the overall annualised bleeding rates were maintained or even further reduced with long-term prophylactic treatment compared to the rates seen in the pivotal studies” |
| 2015-11-24 | Sobi, Inc. | Regulatory Sobi and Biogen's Elocta® (rFVIIIFc) approved in Europe for the treatment of haemophilia A sobi.com ↗ |
| 2015-11-24 | Biogen | Regulatory Sobi and Biogen’s ELOCTA® (rFVIIIFc) Approved in Europe for the Treatment of Haemophilia A biogen.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and Biogen (NASDAQ: BIIB) today announced that the European Commission (EC) has approved ELOCTA ® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. |
| 2015-09-25 | Sobi, Inc. | Regulatory Biogen and Sobi receive positive opinion from CHMP for Elocta(TM) (rFVIIIFc) for the treatment of Haemophilia A sobi.com ↗ |
| 2015-09-25 | Biogen | Regulatory Biogen and Sobi Receive Positive Opinion from CHMP for ELOCTA™ (rFVIIIFc) for the Treatment of Hemophilia A biogen.com ↗
Biogen (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of ELOCTA ™ (rFVIIIFc). |
| 2014-10-31 | Sobi, Inc. | Regulatory Biogen Idec and Sobi announce European Medicines Agency validates Elocta(TM) (rFVIIIFc) Marketing Authorisation Application for review sobi.com ↗
The validation of the MAA initiates the EMA's review process. |
| 2014-10-31 | Biogen | Regulatory Biogen Idec and Sobi Announce European Medicines Agency Validates ELOCTA™ (rFVIIIFc) Marketing Authorization Application for Review biogen.com ↗
The validation of the MAA initiates the EMA’s review process. |
| 2014-10-09 | Sobi, Inc. | Regulatory Sobi's collaboration partner Biogen Idec files marketing authorisation application for Elocta(TM) (rFVIIIFc) in Europe sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that Biogen Idec has submitted a Marketing Authorisation Application (MAA) for Elocta (rFVIIIFc) to the European Medicines Agency (EMA). |
| 2014-04-10 | Sobi, Inc. | Results Biogen Idec and Sobi announce positive top-line efficacy and safety results from phase-3 paediatric study of investigational therapy Eloctate(TM) (rFVIIIFc) for haemophilia A sobi.com ↗
Efficacy analyses showed twice-weekly prophylactic dosing with Eloctate maintained low bleeding rates in children. |
| 2014-04-10 | Biogen | Results Biogen Idec and Sobi Announce Positive Top-Line Efficacy and Safety Results from Phase 3 Pediatric Study of Investigational Therapy Eloctate™ (rFVIIIFc) for Hemophilia A biogen.com ↗
Efficacy analyses showed twice-weekly prophylactic dosing with ELOCTATE maintained low bleeding rates in children. |
| 2014-01-29 | Biogen | Results Biogen Idec 2013 Total Revenues Increase 26 Percent to $6.9 Billion biogen.com ↗
Results from the A-LONG study showed that people with severe hemophilia A may achieve effective prevention or reduction of bleeding episodes with one or two prophylactic infusions a week, potentially fewer than the current standard of care. |
| 2013-12-09 | Sobi, Inc. | Results Swedish Orphan Biovitrum AB (publ): New phase 3 data confirm long-lasting characteristics of rFIXFc and rFVIIIFc across multiple haemophilia populations sobi.com ↗ |
| 2013-12-03 | Biogen | Results Biogen Idec Demonstrates Commitment to Advancing Hemophilia Research and Care at Annual ASH Meeting biogen.com ↗
New, Interim Phase 3 Data Highlight Prolonged Half-Life of ELOCTATE™ and ALPROLIX™ in Young Children |
| 2013-11-13 | Biogen | Results Leading Hematology Journal Publishes Pivotal ELOCTATE™ Data that Demonstrated Efficacy and Safety of Investigational Long-Lasting Therapy for Hemophilia A biogen.com ↗
Results from the A-LONG study showed that people with severe hemophilia A may achieve effective prevention or reduction of bleeding episodes with one or two prophylactic infusions a week. |
| 2013-07-04 | Sobi, Inc. | Results Biogen Idec and Sobi Present New Data from the Phase 3 Study of their Long-Lasting Haemophilia Factor Candidate ELOCTATE(TM) sobi.com ↗ |
| 2013-07-04 | Biogen | Results Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate ELOCTATE™ biogen.com ↗
An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on demand) treatment arms of the phase 3 A-LONG study showed that more than 87% of bleeds were controlled with a single injection of ELOCTATE and more than 97% of were controlled with two or fewer injections. |
| 2013-06-24 | Biogen | Results Biogen Idec Showcases Commitment to Advancing Hemophilia Treatment and Care at ISTH Congress biogen.com ↗
New Phase 3 Data Support Potential Efficacy, Safety and Pharmacokinetics of Long-Lasting Factor Product Candidates |
| 2013-05-13 | Biogen | Regulatory FDA Accepts Biogen Idec’s Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A biogen.com ↗
Biogen Idec (NASDAQ: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. |
| 2013-03-12 | Biogen | Regulatory Biogen Idec Submits Application to FDA for First Long-Lasting Factor VIII Therapy for Hemophilia A biogen.com ↗
Biogen Idec (NASDAQ: BIIB) announced today that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. |
| 2012-10-31 | Sobi, Inc. | Results BIOGEN IDEC AND SOBI ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY INVESTIGATING LONG-LASTING RECOMBINANT FACTOR VIII FC FUSION PROTEIN IN HEMOPHILIA A sobi.com ↗
Top-line results from A-LONG, a global, multi-center, Phase 3 clinical study of the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), showed that rFVIIIFc was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. |
| 2012-10-31 | Biogen | Results Biogen Idec and Sobi Announce Positive Top-Line Results from Phase 3 Study Investigating Long-Lasting Recombinant Factor VIII Fc Fusion Protein in Hemophilia A biogen.com ↗
Top-line results from A-LONG, a global, multi-center, Phase 3 clinical study of the companies’ long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), showed that rFVIIIFc was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. |
| 2011-07-26 | Sobi, Inc. | Results BIOGEN IDEC AND SWEDISH ORPHAN BIOVITRUM PRESENT DATA ON LONG-LASTING RECOMBINANT FACTOR VIII THERAPY AT INTERNATIONAL SOCIETY ON THROMBOSIS AND HAEMOSTASIS MEETING sobi.com ↗
Results from the Phase 1/2a study show that rFVIIIFc has an extended half-life, which may have the potential to provide extended protection from bleeding and reduce the number of infusions necessary for prophylactic treatment of severe hemophilia A. |
| 2011-07-26 | Biogen | Results Biogen Idec and Swedish Orphan Biovitrum Present Data on Long-Lasting Recombinant Factor VIII Therapy at International Society on Thrombosis and Haemostasis Meeting biogen.com ↗
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced Phase 1/2a trial data showing that the companies’ long-lasting fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) was well tolerated and demonstrated an approximately 1.7-fold increase in half-life compared with Advate ® (antihemophilic factor recombinant, plasma/albumin-free method, rFVIII), a commercially-available factor VIII product, in 16 previously-treated patients with severe hemophilia A. |
| 2010-12-23 | Sobi, Inc. | Regulatory Swedish Orphan Biovitrum's Long-Lasting Hemophilia A Therapy Receives Orphan Drug Designation in the US sobi.com ↗ |
| 2010-07-09 | Biogen | Results Biogen Idec and Swedish Orphan Biovitrum Announce Decision to Advance Long-Lasting Hemophilia A Therapy into a Registrational Trial biogen.com ↗
Preliminary results demonstrated that rFVIIIFc’s prolonged half-life compared to Advate was seen consistently across all patients and dose levels, and other measures of pharmacokinetics including mean residence time and area under the curve were also increased. |
All press releases naming this drug 48 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rFVIIIFc | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01027377 ↗ |
| Known as | BIIB031 | “Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A” NCT01458106 ↗ |
| Known as | Factor VIII, recombinant human with Fc fusion | “Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)” NCT06137092 ↗ |
| Known as | recombinant factor VIII Fc fusion protein | “Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study.” PMID 32227570 ↗ Mar 2020 |
| Known as | Recombinant Human Coagulation Factor VIII Fusion Protein | “An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and...” NCT01454739 ↗ |
| Known as | recombinant human Factor VIII Fc fusion protein | “The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A.” NCT01454739 ↗ |
| Action | Restore | “Prophylactic factor replacement” PMID 25912075 ↗ Apr 2015 |
| Modality | Protein / enzyme biologic | “rFVIIIFc is a recombinant fusion protein composed of a single molecule of FVIII covalently linked to the Fc domain of human IgG(1) to extend circulating rFVIII t(1/2).” PMID 22223821 ↗ Jan 2012 |
| Route | Intravenous | “single high dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single high dose intravenous injection of rFVIIIFc with...” NCT01027377 ↗ |