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Last update 16 May 2025

Efmoroctocog alfa(Sobi Analytics)

Last update 16 May 2025

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 KKSanofi-Aventis Australia Pty Ltd.

+ [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

/ RecruitingNot 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

NCT04690322

/ RecruitingPhase 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

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-

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)

154

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

01 May 2025·THROMBOSIS RESEARCH

FVIII half-life products: A real-world experience

Article

Author: Napolitano, Angela ; Simion, Chiara ; Simioni, Paolo ; Zanon, Ezio ; Porreca, Annamaria

BACKGROUND:

Haemophilia A is a genetic coagulation disorder requiring prophylactic Factor VIII (FVIII) treatment to prevent joint damage and enhance quality of life. The introduction of extended half-life (EHL) FVIII products represents a major advancement, addressing patient needs for reduced infusion frequency, improved efficacy, and enhanced safety.

METHODS:

This single-centre observational study examined the real-world use of FVIII products among 124 male patients treated at the Haemophilia Centre of Padua from January 2018 to December 2023. Data on patient characteristics, treatment regimens, and pharmacokinetic profiles were analyzed.

RESULTS:

Among the FVIII products used, Advate®, Elocta®, and Jivi® showed median half-lives of 11.25 [10.75-12.25], 16.50 [13.75-17.75], and 15.38 [13.38-18.63] hours, respectively. Esperoct® exhibited the longest half-life at 19.75 [16.00-24.50] hours, enabling reduced infusion frequency. EHL products showed significantly lower weekly infusion rates compared to standard half-life (SHL) products (1.4 [1.0-2.0] vs. 2.0 [2.0-3.0], p < 0.001), with comparable bleeding control among the different FVIII-EHL.

CONCLUSIONS:

EHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care.

01 Mar 2025·HAEMOPHILIA

In vitro combined haemostatic efficacy of emicizumab and extended half‐life factor VIII compounds

Article

Author: Désage, Stéphanie ; Leuci, Alexandre ; Lienhart, Anne ; Dargaud, Yesim ; Nougier, Christophe ; Josset, Laurie ; Rezigue, Hamdi

Abstract:

Introduction:

Early prophylaxis is the gold standard of care for severe haemophilia. The development of subcutaneous Factor VIII (FVIII) mimetics, such as emicizumab, has significantly reduced the disease burden and improved protection against bleeding episodes. Despite its benefits, emicizumab does not fully normalize haemostasis, requiring additional FVIII treatment for surgical procedures and management of breakthrough bleeding. In these cases, extended or ultra‐extended half‐life FVIII products are most commonly used. However, laboratory monitoring of these combinations can be challenging.

Aim:

This study investigates the in vitro combined haemostatic activity of emicizumab with efmoroctocog alfa and efanesoctocog alfa using a thrombin generation assay (TGA).

Results and Conclusion:

TGA can be used to monitor combined treatment with emicizumab and either efmoroctocog alfa or efanesoctocog alfa, which is not possible with currently available FVIII reagents for the latter. As expected, there is no synergistic effect between the mimetic and FVIII at therapeutical doses. Both efmoroctocog alfa and efanesoctocog alfa show similar in vitro procoagulant activity in terms of thrombin generation.

01 Mar 2025·Research and Practice in Thrombosis and Haemostasis

Hematopoietic stem cell transplantation in a newborn suffering from severe combined immunodeficiency and severe hemophilia A: a case report and review of the literature

Article

Author: Schulte, Johannes ; Schober, Sarah ; Döring, Michaela ; Lang, Peter ; Olivieri, Martin ; Icheva, Vanya

Background:

Severe combined immunodeficiency (SCID) and severe hemophilia A are 2 rare and potentially life-threatening congenital diseases. The coincidence of these diseases has not been reported so far.

Key Clinical Question:

We present the first case of a newborn with both diseases. SCID can be treated with hematopoietic stem cell transplantation (HSCT). However, how to successfully manage a newborn with severe hemophilia A during intensive HSCT treatment is the key clinical question of this case report.

Clinical Approach:

Prophylactic factor (F)VIII substitution during HSCT was performed with an extended half-life FVIII product (efmoroctocog alfa). The platelet count was a major factor influencing the dosage of FVIII. No bleeding complications or FVIII inhibitors occurred during this individualized management.

Conclusion:

This is the first case report of a newborn suffering from both SCID and severe hemophilia A. HSCT is feasible in this situation without bleeding complications if an individual substitution regimen with FVIII is applied.

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

24 Apr 2025

·www.fiercepharma.com

Sanofi and Regeneron's high-flying Dupixent on course for an 'inflection year' in COPD

Sanofi said that the launch of Dupixent in COPD is off to a promising start. The company called 2025 an 'inflection year," for uptake of the product in the indication. As Sanofi anticipates sales of immunotherapy juggernaut Dupixent reaching a major $22 billion by the end of the decade, fulfilling that goal will hinge on its uptake in chronic obstructive pulmonary disorder (COPD).So far, so good.After gaining FDA approval in the indication in September of last year, the company is on a “record-setting pace,” as it relates to coverage, according to Brian Foard, Sanofi’s head of specialty care, speaking at the company’s first quarter conference call.Medicare and commercial coverage are at 90% and 88% respectively, Foard said, adding that “as you look at initiations we’re seeing, it’s our most rapid respiratory initiation launch so far.”COPD represents a significant opportunity for Sanofi and its U.S. drug partner Regeneron as Dupixent is the first biologic approved for the condition, which is the fourth-leading cause of death in the world. With many patients having “resigned themselves to their condition,” according to Sanofi CEO Paul Hudson, the company is busy educating pulmonologists and patients about the benefits of the treatment.Sanofi has launched Dupixent for COPD in eight countries, said Hudson, who added that 2025 will be the "inflection year," for the treatment in the indication. Last week, the FDA approved Dupixent in its seventh indication—the hives disorder chronic spontaneous urticaria (CSU). The company expects another nod this year for Dupixent to treat the skin disease bullous pemphigoid (BP).The company reported Q1 sales of Dupixent at 3.5 billion euros ($4 billion), which was an impressive increase of 20% year over year. In 2024, Dupixent sales came in at $14.1 billion, which was an increase of 22% from 2023.Dupixent’s trajectory contributed heavily to Sanofi’s strong quarterly performance. The company racked up sales of 9.9 billion euros ($11.3 billion) in the first quarter, which was a 10% increase year-over-year. Also playing a role was hemophilia A treatment Altuviiio, which made a 100% leap in sales to 251 million euros ($285 million) and “has the potential to become our next blockbuster this year,” Hudson said.Hudson added that Altuviiio, which was approved in early 2023, is “benefiting from patient switches,” as they move away from factor VIII replacement medicines, such as the company’s aging Eloctate, which saw a 21% decline in sales to 70 million euros ($80 million) in the quarter.Meanwhile, sales of Sanofi’s factor VIX replacement treatment Alprolix—which was approved for hemophilia B patients three months before Eloctate in 2014—grew by 20% to 160 million euros ($182 million).

Drug ApprovalImmunotherapyClinical ResultBiosimilar

24 Apr 2025

·endpts.com

Sanofi's Altuviiio closing in on blockbuster status, Dupixent sales surge

Sanofi posted a strong set of first-quarter results Thursday morning, with its recombinant factor drug Altuviiio on track to become a blockbuster drug and its crown jewel Dupixent continuing to draw sales. Sales of the French drugmaker’s hemophilia A treatment Altuviiio doubled in the first quarter to €251 million ($286 million), according to a company earnings report . Almost 90% of that number was driven by the US, where patients continued to switch over from older plasma-derived and recombinant factor medicines. The remaining €33 million came from other markets, boosted by a recent launch in Japan. Altuviiio has been steadily gaining market share since it secured FDA approval in 2023, according to Sanofi. If it can replicate its Q1 sales for the rest of the year, the product should reach blockbuster status in 2025, a company spokesperson told Endpoints News in an email. Altuviiio is administered weekly, giving it a significant convenience edge over older recombinant factor drugs, which can require up to thrice weekly dosing. Sanofi’s older recombinant factor medicine, Eloctate, saw sales drop around 21% to €70 million as patients switched to Altuviiio. But its broader hemophilia A franchise fared positively, with sales rising by 50% to €321 million. That number formed part of Sanofi’s total first-quarter sales of €9.9 billion, which were up almost 10% from the same time last year. The figure came in 3% ahead of Wall Street consensus forecasts and was driven by continued growth of the company’s blockbuster inflammatory disease drug Dupixent, Jefferies analysts said in a Thursday note. Dupixent sales were up around 20% in the quarter to €3.5 billion. The growth was driven by rising use in all established indications, as well as “emerging use” in its latest approval for chronic obstructive pulmonary disorder, Sanofi said. Dupixent is expected to reach peak sales of $3.3 billion in COPD alone, according to Wall Street consensus estimates. Sanofi’s hemophilia offering was further bolstered by an FDA approval for siRNA medicine Qfitlia in hemophilia A and B last month. Qfitlia will be sold in the US at an average cost of $642,000 per year, but comes with a boxed warning for thrombotic events and gallbladder disease. Sanofi also reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. The drug did not hit statistical significance in the primary endpoint of PASI-75, which measures the proportion of patients with a minimum 75% improvement in their psoriasis area and severity index score. Sanofi said the failure was driven by “the limited nature” of the trial, adding it would share full data at a future medical meeting. For now, the company is considering potential combination approaches for balinatunfib. Elsewhere, Sanofi made several cuts to its cancer pipeline. The drugmaker terminated a Phase 2 trial for NK cell engager SAR443579 in acute myeloid leukemia and a Phase 1 study of monoclonal antibody SAR444881 in solid tumors. The cuts are part of a broader pipeline prioritization that should help the company focus on its goal of becoming a world leader in immunology, the spokesperson said. On a call with the media on Thursday, CFO François Roger said the company is continuing to assess how the looming pharma tariffs would impact its business. Editor’s Note: This article was updated to add information about the balinatunfib trial failure and the company’s comments on potential pharma tariffs.

Drug ApprovalPhase 2Phase 1

23 Apr 2025

·www.prnewswire.com

Sobi presents clinical data at WFH 2025 Comprehensive Care Summit

STOCKHOLM, April 23, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) presents clinical data aimed at updating the global haemophilia community attending this year's WFH 2025 Comprehensive Care Summit in Dubai from the 23 – 25 April. New and updated outcomes and analyses will be presented from the XTEND phase 3clinical program testing the effectiveness of Altuvoct® (efanesoctocog alfa) treatment for haemophilia A, including updates on patients' joint health and surgical outcomes in patients. "At WFH 2025 CCS, Sobi will present highlights from the XTEND phase 3 program and discuss the new treatment paradigm with FVIII levels in the non-haemophilia range. Sharing these clinical outcomes with the wider haemophilia community will help to ensure the latest treatment approaches are widely known and understood," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi. Key data to be presented at WFH 2025 Comprehensive Care Summit, Dubai, UAE Altuvoct® (efanesoctocog alfa) About efanesoctocog alfa Efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a novel and significant part of the week factor VIII therapy. It has the potential to deliver near-normal factor activity levels for significant parts of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. Efanesoctocog alfa builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. It was approved as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the US in February 2023. About the Sobi and Sanofi 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, referred to as ALTUVIIIO™ in the USA and ALTOVUCT in Europe. An investigational factor VIII therapy with the potential to provide high sustained factor activity levels with once-weekly dosing for people with haemophilia A. 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. Sobi® Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East and Asia. In 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Contact 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

Phase 3Drug ApprovalBiosimilar

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.

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

Developing

10 top R&D records.

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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


NCT01181128 \| NCT01458106 \| NCT01454739 (Kids A-LONG \| A-LONG \| ASPIRE, Pubmed \| Ther Adv Hematol)	Phase 3	Hemophilia A	-	Efmoroctocog alfa prophylaxis	zzwwarpzyp(bspooxjbfe) = udtdwilipg lvmufckfjc (bytugjvzds )	Positive	01 Jan 2024
	Phase 3	Hemophilia A	-	Placebo	zzwwarpzyp(bspooxjbfe) = mutdminkvc lvmufckfjc (bytugjvzds )	Positive	01 Jan 2024
NCT03093480 (verITI-8, Pubmed \| Blood)	Phase 4	-	16	Recombinant Factor VIII Fc Fusion Protein (efmoroctocog alfa; rFVIIIFc)	gemjsmtuqk(ehrovbbqob) = ocmxwlamvc wfljuvfsyz (jfmsgdlpce ) View more	-	03 Feb 2023
NCT02976753 (A-SURE, Corporate Publications) Manual	Not Applicable	Hemophilia A	-	Efmoroctocog alfa	yinuupyewp(ylrvulsimg) = Results showed statistically significant improvements in all three primary endpoints mztssyicud (uthvlgbpof ) 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	jbuvqkevle(vgtnfaycvb) = wadiaqzpbo ugcxwkjkff (urdvquxwxw )	Positive	09 Jul 2022
ISTH2022	Not Applicable	Hemophilia A	20	rFVIIIFc	jbuvqkevle(vgtnfaycvb) = pflrtqahdd ugcxwkjkff (urdvquxwxw )	Positive	09 Jul 2022
NCT03103542 (ReITIrate, CTgov)	Phase 4	Hemophilia A	16	Recombinant coagulation factor (rFVIIIFc)	exrqjpfczz(mfpljfzbww) = mtxtzlywem shzxdojwxy (bjzrwcmsdc, 0) View more	-	30 Nov 2021
NCT03103542 (ReITIrate, ISTH2021)	Phase 4	-	16	rFVIIIFc (200 IU/kg/day)	aqenwsgkuo(iewwmludkb) = llimseczxk kvzwnvfhmn (lxatersjnh ) View more	-	17 Jul 2021
NCT03093480 (verITI-8, CTgov)	Phase 4	Hemophilia A	16	rFVIIIFc	txkqjulkla(cdsoahuwxf) = kjfwznwtll ugyyaesowj (jvaonpeugj, ricprkygvj - qrddnaykes) View more	-	07 Jul 2021
NCT02234323 (ASH2020) Manual	Phase 3	Hemophilia A First line	103	Efmoroctocog alfa	ekzifrehml(zkujsgrznw) = nacrxxmxse dfibmxjonm (nxxpixaauz ) View more	Positive	07 Nov 2020
NCT02234323 (PUPs A-LONG, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	108	rFVIIIFc	vzpyaexmxw = jryukdasqp bhonuepovb (wndavdmfna, byfjlxtcpz - imjuvwumic) View more	-	13 Aug 2020
ISTH2020	Not Applicable	First line	-	rFVIIIFc	groxismgjp(olsgfpwown) = ynmvoqhkrm xagonnumre (jixsklsshh )	-	12 Jul 2020
ISTH2020	Not Applicable	First line	-	Emicizumab	groxismgjp(olsgfpwown) = obvqyhegmx xagonnumre (jixsklsshh )	-	12 Jul 2020

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