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Last update 06 Jun 2026

Efmoroctocog alfa(Sobi Analytics)

Last update 06 Jun 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fc fusion protein, Recombinant coagulation factor

Synonyms

Antihemophilic Factor (Recombinant BDD), FC Fusion Protein, Antihemophilic Factor (Recombinant), Fc Fusion protein, Antihemophilic factor (recombinant, FC fusion protein)

+ [18]

Target

F10

Action

modulators

Mechanism

F10 modulators(Coagulation factor X modulators), Coagulation factor VIII replacements

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia A

Inactive Indication

Hemorrhage

Originator Organization

Sobi Analytics Ltd.

Active Organization

Swedish Orphan Biovitrum ABSanofi KK

Biogen, Inc.

+ [1]

Inactive Organization

Bioverativ, Inc.

Bioverativ Therapeutics, Inc.

License Organization

Biogen, Inc.

Swedish Orphan Biovitrum AB

Bioverativ Therapeutics, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (06 Jun 2014),

Hemophilia A

Regulation-

Structure/Sequence

Sequence Code 169138

Source: *****

Sequence Code 611893858

Source: *****

Clinical Trials associated with Efmoroctocog alfa(Sobi Analytics)

NCT06158334

/ Unknown statusNot ApplicableIIT

Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)

Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy.
In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.
Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.

Start Date01 Jun 2022

Sponsor / Collaborator

Hospices Civils de Lyon

NCT04728217

/ CompletedPhase 4IIT

Health Related Quality of Life of Youth and Young Adults With Haemophilia A Treated With Efmoroctocog Alfa in Russia

Research question:
Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?
A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.

Start Date15 Apr 2021

Sponsor / Collaborator-

NCT04690322

/ WithdrawnPhase 4IIT

POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

This is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor VIII based replacement therapy or non-FVIII based replacement therapy, which are both standard of care treatment for persons with Hemophilia A.

Start Date15 Apr 2021

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

100 Clinical Results associated with Efmoroctocog alfa(Sobi Analytics)

100 Translational Medicine associated with Efmoroctocog alfa(Sobi Analytics)

100 Patents (Medical) associated with Efmoroctocog alfa(Sobi Analytics)

134

Literatures (Medical) associated with Efmoroctocog alfa(Sobi Analytics)

31 Dec 2025·Hematology

A-SURE: intra-patient comparison of prophylactic effectiveness of a recombinant factor VIII Fc fusion protein versus standard half-life factor VIII in hemophilia A

Article

Author: Anna-Elina Lehtinen ; Eva Bednar ; Flora Peyvandi ; Stefan Lethagen ; Charles Hay ; Ingrid Pabinger ; Håkan Malmström ; Johannes Oldenburg ; Eveline Nüesch

BACKGROUND:

Despite recent advances, factor replacement therapy remains a cornerstone in hemophilia A treatment. Efmoroctocog alfa, a recombinant FVIII Fc fusion protein (rFVIIIFc), has an extended half-life allowing higher FVIII levels and less frequent dosing than standard half-life (SHL) products, without increasing factor consumption.

METHODS:

A-SURE was a 24-month prospective, non-interventional study assessing real-world effectiveness of rFVIIIFc prophylaxis. This post-hoc, intra-patient analysis included patients with hemophilia A (PwHA) who switched from SHL FVIII to rFVIIIFc prophylaxis. Effectiveness endpoints included annualised bleeding rate (ABR), annualised joint bleeding rate (AjBR), weekly injection frequency and weekly factor consumption.

RESULTS:

Of 131 PwHA eligible for analysis, mean ABR and AjBR decreased from 3.7 and 2.4 to 1.8 and 1.1, respectively, after switching (mean [95% confidence interval (CI)] change of -1.9 [-3.0, -0.8] and -1.2 [-2.0, -0.5]). Mean weekly injection frequency decreased from 3.1 to 2.3 (mean [95% CI] change of -0.8 [-1.0, -0.7]); weekly factor consumption reduced from 89.7 to 84.1 international units (IU)/kg, respectively (mean [95% CI] change of -5.7 [-10.7, -0.6]). These trends were consistent across age groups.

CONCLUSION:

This intra-patient comparison demonstrates switching from SHL FVIII to rFVIIIFc prophylaxis reduces frequency of bleeds, injection frequency, and factor consumption, complementing previously reported data from A-SURE.Trial registration:ClinicalTrials.gov identifier: NCT02976753.

26 Nov 2025·Expert Review of Pharmacoeconomics & Outcomes Research

Switching hemophilia A patients to an extended half-life agent on a prophylactic basis: an economic appraisal

Article

Author: Ariston Karagiorgis ; Sofia Vakalopoulou ; Efrosyni Nomikou ; Helen Pergantou ; Konstantinos Drakos ; Olga Katsarou ; Marina Economou

BACKGROUND:

Gaining an understanding of transitioning hemophilia patients to an extended half-life (EHL) agent requires real-world data, encompassing various outcomes, which would help assessing the impact of the switch, for patients and the healthcare system. We investigate the economic implications of switching from standard half-life (SHL) recombinant factor VIII (rFVIII) from either prophylaxis or on-demand, to EHL rFVIII efmoroctocog alfa (FVIIIFc) prophylaxis.

RESEARCH DESIGN AND METHODS:

The study involved 48 patients with hemophilia A from the 5 specialized hemophilia centers in Greece. Patients switched from prophylactic or on-demand treatment using a SHL factor VIII to a rFVIIIFc on prophylaxis only. Data was gathered for the 12-month period before and after switch. Using standard t-tests and regression analysis, we compared the direct treatment cost between the pre and post switch time, focusing on regimens' differential costs.

RESULTS:

There is no statistically significant cost increase compared to the core rFVIII regimen used before the switch, when only patients that were previously on prophylaxis were considered. However, there is a statistically significant reduction in cost across treatment styles.

CONCLUSIONS:

The analysis confirms the advantages offered by prophylaxis with rFVIIIFc from an economic standpoint for the Greek healthcare system, in accordance with other studies.

01 Aug 2025·CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS

Clinical and Surgical Experiences with Efmoroctocog Alfa in Pediatric Population with Hemophilia A

Article

Author: Solgun, Hüseyin Avni ; Ozay, Mustafa

Introduction:

Hemophilia A is a rare inherited bleeding disorder. Less than 1% of FVIII level in plasma is classified as severe, 1%–5% as moderate, and above 5% as mild disease. The aim of this study is to share clinical and surgical experiences in Hemophilia A with extended half-life (EHL) recombinant FVIII preparations.

Material and Methods:

A retrospective observational study between 2024 and 2025, inpatient or outpatient follow-up was carried out in the Pediatric Hematology clinic of our university hospital. A total of 18 patients diagnosed with severe FVIII deficiency were included in this study.

Results:

The average age of the patients was 8.4 years (min. 20 months—max. 17 years). All patients were male and inhibitor negative severe FVIII deficiecy patients. Patients were numbered as P1-18 respectively. P1, P4, and P8 are 20 months, 3 years, and 4 years old respectively. They were evaluated as previously untreated patients (PUP) with a new diagnosis of severe FVIII deficiency and the other patients were previously treated patients (PTPs). P10 had 2 infected decayed molars and 1 incisor extracted in the same dental session. P13 underwent circumcision operation. P18 had refixation surgery due to a left arm radius and ulna bone fracture, and a cast was applied. All three surgical operations were performed under treatment of recombinant FVIII Efmoroctocog alfa (Ealfa/Elocta ® ) successfully.

Conclusion:

Efmoroctocog alfa seems to be effective in EHL FVIII replacement therapy and surgical management of hemophilia A. Compared with standard half-life (SHL) FVIII products, EHL FVIII products such as Ealfa have the potential to optimize prophylactic outcomes by decreasing the burden of treatment or increasing the level of bleed protection.

News (Medical) associated with Efmoroctocog alfa(Sobi Analytics)

20 Mar 2026

·www.fiercepharma.com

Sanofi backs 2 more documentary films about rare blood disorders

One of the films will follow the efforts of the Hemophilia Foundation of Nigeria, led by Megan Adediran, to increase hemophilia diagnoses via a fleet of mobile medical vans. Not long after lending its support to a documentary aimed at shining a light on the often-overlooked stories of women with hemophilia, Sanofi is continuing its film-focused collaboration with patient engagement agency Believe Limited.The French pharma is supporting another two full-length documentaries from Believe Limited about rare blood disorders, the duo announced this week.One of the films will follow the efforts of the Hemophilia Foundation of Nigeria, led by Megan Adediran, to increase hemophilia diagnoses via a fleet of mobile medical vans. The other is set in the U.S., where it will chart the barriers to widespread awareness, access and advocacy that many with hemophilia face.Both films are now in production, with release timelines still to be announced. Both releases will be accompanied by “impact campaigns, educational resources and community screenings designed to extend awareness beyond the screen,” according to the companies. “These documentaries represent more than a collaboration between Sanofi and Believe Limited, it’s a commitment to ensuring patient voices are heard, seen and felt across the rare blood disorder community,” Jeff Schaffnit, general manager of U.S. rare blood disorders at Sanofi, said in the announcement. “By bringing together these powerful stories, we’re shining a light on the shared experiences that connect patient journeys—the challenges, the resilience, and the courage it takes to navigate life with a rare blood disorder,” Schaffnit continued. “But more than that, we’re honoring the healing power of advocacy, education and community—the very forces that continue to shape how we show up for these patients every day.” Sanofi is the maker of several treatments for hemophilia, including Qfitlia, Altuviiio, Alprolix and Eloctate.Last summer, the Big Pharma announced its support for “Dismissed,” a film documenting five women’s experiences with hemophilia. The disease is typically associated with men, with many people mistakenly believing that women can only be benign carriers of the disease; Sanofi has separately joined efforts to correct that common misconception about X-linked disorders.Before that, Sanofi previously worked with Believe Limited on “Let’s Talk,” a 2020 documentary digging into the mental health struggles faced by people with bleeding disorders.

24 Jul 2025

·www.fiercepharma.com

Sanofi lends support to ‘Dismissed’ film about 5 women’s experiences with hemophilia

This isn’t the first time Sanofi has sponsored a film spotlighting the experiences of people with bleeding disorders. In 2020, the Big Pharma lent its financial support to another Believe Limited production called “Let’s Talk.” A soon-to-be-released documentary film aims to change the conversation around hemophilia, a condition in which many female patients go misdiagnosed for years and often feel ignored or overlooked by healthcare providers.Sanofi provided financial support for the film, which was produced by patient engagement agency Believe Limited. The French drugmaker sells several treatments for the bleeding disorder, including Qfitlia, Altuviiio, Alprolix and Eloctate.“Dismissed” is slated to premiere on Aug. 22 at the National Bleeding Disorders Foundation’s (NBDF’s) Bleeding Disorders Conference in Colorado.The film follows four women diagnosed with hemophilia—a 15-year-old patient advocate, a mother-to-be looking for a clear treatment plan, a woman left paralyzed by a preventable complication and the chief operating officer of the NBDF—as well as a mother of two sons with the disease who begins to suspect her own longtime symptoms might be due to undiagnosed hemophilia.The documentary catalogues the women’s struggles with misdiagnoses, lack of treatment plans and the feeling of being dismissed by doctors, as well as their efforts to care for family members with the disease and advocate for the broader hemophilia community. Hemophilia is typically associated with men, and many people mistakenly believe that women can only be benign carriers of the disease—a common misconception about X-linked disorders that Sanofi is also working to correct.According to statistics cited by the film’s makers, 80% of hemophilia clinical trials recruit only men. Nearly 60% of healthcare providers have reported diagnostic delays for women with hemophilia, with Black women often experiencing even more significant delays due to systemic and racial biases in the healthcare system. The film’s website offers several resources for viewers who want to further support the hemophilia community, including downloadable social media assets to spread the word about the documentary; a “screening toolkit” of educational information, activity ideas and tips for empowering women in conversations with their doctors; and a link to “be part of the solution” by locating nearby clinical trials.“The women in this film have been dismissed time and time again, and their stories demand attention,” Bella Gadsby, the film’s director, said in a statement. “Working at Believe Limited, I’ve witnessed firsthand the impact of advocacy and the power of storytelling in shifting perspectives. This film is not just about hemophilia; it’s about the systemic silencing of women and the urgent need to change the narrative. ‘Dismissed’ is not just a documentary, it’s a declaration.”This isn’t the first time Sanofi has sponsored a film spotlighting the experiences of people with bleeding disorders: In 2020, the Big Pharma lent its financial support to another Believe Limited production, “Let’s Talk,” which homed in on the mental health aspect of life with hemophilia and other bleeding disorders.Elsewhere, in 2023, the company released the results of a survey it began shortly after Altuviiio’s FDA approval, highlighting hemophilia patients’ unmet needs and hopes for future treatments.

Clinical Study

20 Jun 2025

·www.prnewswire.com

Sobi will showcase extensive research and clinical outcomes at ISTH 2025

STOCKHOLM, June 20, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) will be presenting a wide range of clinical study updates at the annual International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington (21-25 June). With ten (10) presentations, Sobi's clinical teams will showcase new data for avatrombopag to treat children with ITP, surgery outcomes using efanesoctocog alfa, and abstracts on specific long-term haemophilia studies. "Attending ISTH is an important part of our commitment to collaboration and knowledge sharing so we can further advance treatments for those living with haemophilia, immune thrombocytopenia, and other rare blood conditions", said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. "We are proud to be showcasing abstracts as part of the ISTH programme, including Doptelet abstracts that present new data related to children living with ITP, Altuvoct outcomes for perioperative management, and joint health outcomes from a long-term extension study, as well as final outcomes from the B-MORE study. Many people living with rare conditions have unmet needs, and we are proud to present additional data advancing treatments for these rare conditions." Data to be presented at ISTH 2025 All abstracts are accessible through the official ISTH website. However, any late-breaking abstracts will only be made available later. About ALTUVOCT® (efanesoctocog alfa) ALTUVOCT® (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A. ALTUVOCT can be used for all age groups and any disease severity. About Elocta®/Eloctate® (efmoroctocog alfa) Elocta®/Eloctate® (efmoroctocog alfa) is a treatment and prophylaxis of bleeding in patients with haemophilia A. Elocta/Eloctate can be used for all age groups. About Alprolix® (eftrenonacog alfa) Alprolix® (eftrenonacog alfa) is a treatment and prophylaxis of bleeding in patients with haemophilia B. Alprolix can be used for all age groups. About Doptelet® (avatrombopag) Doptelet® (avatrombopag) is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, and a treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. About Sobi Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Sanofi apply deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Sanofi's team is guided by one purpose: to chase the miracles of science to improve people's lives; this inspires Sanofi to drive progress and deliver positive impact for Sanofi's people and the communities Sanofi serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN andNASDAQ: SNY About the Sanofi and Sobi collaboration Sobi and Sanofi collaborate on the development and commercialisation of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialisation of efanesoctocog alfa, or ALTUVIIIO ® in the US, Japan, and Taiwan, and Altuvoct in Europe. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Efmoroctocog alfa(Sobi Analytics)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Efmoroctocog alfa(Sobi Analytics)	B02BD02	DB11607

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hemophilia A	United States	Biogen, Inc.	06 Jun 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	Japan	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	Austria	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	Belgium	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	Hong Kong	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	India	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	Israel	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	South Africa	Bioverativ Therapeutics, Inc.	01 Nov 2010
Hemorrhage	Phase 3	Switzerland	Bioverativ Therapeutics, Inc.	01 Nov 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02976753 (A-SURE, Pubmed \| Hematology)	Not Applicable	Hemophilia A	131	rFVIIIFc prophylaxis	dqbxemruwz(cmfvjuzsmu) = jxntkfbmvu dlkdogrpyn (nujnywklpx )	Positive	31 Dec 2025
NCT02976753 (A-SURE, Pubmed \| Hematology)	Not Applicable	Hemophilia A	131	SHL FVIII prophylaxis	dqbxemruwz(cmfvjuzsmu) = oergaqeiba dlkdogrpyn (nujnywklpx )	Positive	31 Dec 2025
NCT03103542 (ReITIrate, Pubmed \| Ther Adv Hematol)	Phase 4	-	16	efmoroctocog alfa	pqyhtptzww(zxxyrhpvln) = fvpxtquwvj dcfhcyaujr (oqangufmei ) View more	Positive	01 Jan 2024
NCT01181128 \| NCT01458106 \| NCT01454739 (Kids A-LONG \| A-LONG \| ASPIRE, Pubmed \| Ther Adv Hematol)	Phase 3	Hemophilia A	-	Efmoroctocog alfa prophylaxis	uzuowzvrxx(ilvlajpnsg) = hutqgtyfet yhffpwepnb (uzxvkzritw )	Positive	01 Jan 2024
	Phase 3	Hemophilia A	-	Placebo	uzuowzvrxx(ilvlajpnsg) = vqaphphzbl yhffpwepnb (uzxvkzritw )	Positive	01 Jan 2024
NCT03093480 (verITI-8, Pubmed \| Blood)	Phase 4	-	16	Recombinant Factor VIII Fc Fusion Protein (efmoroctocog alfa; rFVIIIFc)	rkcidvuvwj(whhjagfyej) = dnstqagdgn isxieeokaw (qxhnfoahtm ) View more	-	03 Feb 2023
NCT02976753 (A-SURE, Corporate Publications) Manual	Not Applicable	Hemophilia A	-	Efmoroctocog alfa	lkxtbduvxu(rhwxhjsczx) = Results showed statistically significant improvements in all three primary endpoints vdphbbveuk (gcpuhnmsyi ) View more	Superior	13 Jul 2022
NCT02976753 (A-SURE, Corporate Publications) Manual	Not Applicable	Hemophilia A	-	FVIII		Superior	13 Jul 2022
ISTH2022	Not Applicable	Hemophilia A	20	SHL FVIII	scgowawjde(mxzbbobukh) = uulumtmqod vunucmosdl (xbqbqocdju )	Positive	09 Jul 2022
ISTH2022	Not Applicable	Hemophilia A	20	rFVIIIFc	scgowawjde(mxzbbobukh) = psyiillfdg vunucmosdl (xbqbqocdju )	Positive	09 Jul 2022
NCT03103542 (ReITIrate, CTgov)	Phase 4	Hemophilia A	16	Recombinant coagulation factor	nxlmtmtlwc(bndmpkthxx) = qkwleovivg yizvzggezb (hkcxfdetwf, 0) View more	-	30 Nov 2021
NCT03103542 (ReITIrate, ISTH2021)	Phase 4	-	16	rFVIIIFc (200 IU/kg/day)	wrndwjkkgz(mnkuiomefa) = uutgngqpze ltbbdkkvnx (oagnjenqcn ) View more	-	17 Jul 2021
NCT03093480 (verITI-8, CTgov)	Phase 4	Hemophilia A	16	rFVIIIFc	mnhvjfurac(fbhkmsmuiv) = qewrzakdhw yzbybsoidt (mfgatfkast, erpmzlhfhc - zawhsgalpa) View more	-	07 Jul 2021
NCT02234323 (ASH2020) Manual	Phase 3	Hemophilia A First line	103	Efmoroctocog alfa	buvvhghmha(cqxvivoiti) = pshsfnkcjx vstjucprnh (eipctkzeec ) View more	Positive	07 Nov 2020

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