An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A.

Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.
Participants who are receiving treatment with damoctocog alfa pegol (n
12) or turoctocog alfa pegol (n
12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.
During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).
The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.
Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.

Start Date15 Jan 2025

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

[+1]

NCT06716814

/ Not yet recruitingPhase 3

A Multinational, Prospective, Open-label, Roll-over Study (LIBERTY) to Provide Post-trial Access to Treatment for Patients With Severe Haemophilia A Who Have Completed a Previous Trial With Efanesoctocog Alfa

This is a multinational, prospective, open-label, roll-over study in patients with severe haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), or PK comparison study (Sobi.BIVV001-003). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first).
The study starts with the Baseline Visit, which will be done in connection to the End of Study visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.

Start Date01 Jan 2025

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

[+1]

NCT06752850

/ RecruitingPhase 4

A 12-month, Interventional, Open-label, Phase 4 Study in Europe (SHINE) to Investigate the Course of Synovial Hypertrophy as Detected by Joint Ultrasound and MRI in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis.

The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.

Start Date19 Dec 2024

Sponsor / Collaborator

Swedish Orphan Biovitrum AB

[+1]

100 Clinical Results associated with Efanesoctocog alfa

100 Translational Medicine associated with Efanesoctocog alfa

100 Patents (Medical) associated with Efanesoctocog alfa

Literatures (Medical) associated with Efanesoctocog alfa

02 Jan 2025·Expert Opinion on Drug Metabolism & Toxicology

Pharmacokinetic evaluation of efanesoctocog alfa: breakthrough factor VIII therapy for hemophilia A

Review

Author: Yada, Koji ; Nogami, Keiji

INTRODUCTION:

Blood coagulation factor (F)VIII functions as a cofactor in the tenase complex responsible for phospholipid-dependent FIXa-mediated activation of FX in plasma. Congenital defect of FVIII causes severe bleeding disorder, hemophilia (H) A. Intravenous FVIII replacement therapy is the gold standard therapy in patients with HA (PwHA) but requirement for frequent dosing of FVIII owing to pharmacokinetics burdens PwHA a lot. Efanesoctocog alfa is a new class of recombinant FVIII and has the ability to overcome conceivable unmet needs in treatment for PwHA.

AREAS COVERED:

Efanesoctocog alfa is a B domain-deleted single-chain fusion FVIII connected to the Fc-region of human immunoglobulin G1, D'D3-fragment of von Willebrand factor (VWF), and unstructured hydrophilic recombinant polypeptides (XTEN). Owing to its novel design, it can function independently of endogenous VWF and elicits 2 to 4 times longer half-life compared to other existing FVIII products. The prolonged half-life contributes to maintain high level of FVIII activity for most of the week and has led to excellent hemostatic effect by once-weekly administration in phase 3 clinical trials.

EXPERT OPINION:

Efanesoctocog alfa with outstanding pharmacological properties, well tolerated in the clinical trials, is a promising FVIII therapy for PwHA. Future studies should include long-term safety, especially in previously untreated patients.

01 Jan 2025·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Accurate evaluation of factor VIII activity of efanesoctocog alfa in the presence of emicizumab

Article

Author: Marquez, Elizabeth ; Pipe, Steven W ; Young, Guy ; Dargaud, Yesim ; Huisman, Albert ; Quehenberger, Peter ; Sexton, Edison ; Van Dievoet, Marie-Astrid ; Guery, Eve-Anne ; Nougier, Christophe ; Pouplard, Claire ; Hermans, Cedric ; Pabinger, Ingrid ; Schutgens, Roger E G

BACKGROUND:

Efanesoctocog is a B-domain-deleted, Fc-fusion factor (F)VIII linked to the D'D3 domain of von Willebrand factor and 2 XTEN polypeptides, designed for an ultra-extended half-life for prophylaxis in hemophilia A, but also aiding in managing acute bleeding or surgery in patients on long-term emicizumab. However, no current laboratory method accurately measures FVIII levels in the presence of emicizumab.

OBJECTIVES:

To test whether the bovine chromogenic FVIII assay, specifically calibrated for efanesoctocog, could provide an accurate assessment of efanesoctocog activity.

METHODS:

Seven centers across 5 countries received 12 plasma samples to measure in triplicate using 2 calibration methods across 3 independent days. Samples (n = 6) contained either only efanesoctocog (FVIII activity [FVIII:C]= 5 to 150 IU/dL), or efanesoctocog (FVIII:C = 5 to 150 IU/dL) in combination with emicizumab (50 μg/mL; n = 5). One sample contained efanesoctocog (FVIII:C = 50 IU/dL) and a high dose of emicizumab (80 μg/mL); another sample contained efanesoctocog (FVIII:C = 50 IU/dL) with a low dose of emicizumab (20 μg/mL). Each center used its own analyzers, along with their usual reagents.

RESULTS:

Chromogenic assay (CSA) calibrated with standard calibrators highly overestimates FVIII:C. However, specific calibration with efanesoctocog enabled accurate measurement of FVIII:C, with low inter- and intra-laboratory variability, and no interference from emicizumab. All CSA reagents used in the study demonstrated low variability across different laboratories (interlaboratory coefficient of variation ranges between 9% and 20%).

CONCLUSION:

Specific calibration of the FVIII CSA using efanesoctocog and bovine reagents allows for accurate measurement of FVIII:C in patients receiving efanesoctocog, even in the presence of emicizumab.

01 Jan 2025·ADVANCES IN THERAPY

Efanesoctocog Alfa Versus Emicizumab in Adolescent and Adult Patients With Haemophilia A Without Inhibitors

Review

Author: Arnaud, Alix ; Kragh, Nana ; Wojciechowski, Piotr ; Álvarez Román, María Teresa ; Margas, Wojciech ; Santagostino, Elena ; Wdowiak, Marlena ; Guyot, Patricia ; Wilson, Amanda

INTRODUCTION:

The phase 3 XTEND-1 trial (NCT04161495) demonstrated that efanesoctocog alfa prophylaxis provided superior bleed protection compared with pre-trial factor VIII (FVIII) prophylaxis in patients with severe haemophilia A. The aim of this study was to indirectly compare the efficacy of efanesoctocog alfa with non-factor replacement therapy emicizumab in adolescent and adult patients with severe haemophilia A without inhibitors.

METHODS:

A systematic literature review was conducted to identify phase 3 trials of emicizumab. Matching-adjusted indirect comparisons were used to compare annualised bleeding rates (ABRs) for any, treated, joint, and spontaneous bleeds, and joint health (measured using Hemophilia Joint Health Score [HJHS]), between efanesoctocog alfa and emicizumab. Estimated effects for different emicizumab regimens were pooled using random-effect meta-analysis to evaluate the overall difference in bleed outcomes between efanesoctocog alfa and emicizumab.

RESULTS:

One emicizumab trial was included (HAVEN 3), which investigated three dosing regimens. In meta-analyses, efanesoctocog alfa once-weekly (Q1W) was associated with significantly lower ABRs for any (incidence rate ratio [95% CI] 0.33 [0.20; 0.53]), any treated (0.49 [0.30; 0.80]) and treated joint (0.51 [0.28; 0.91]) bleeds compared with emicizumab Q1W in non-inhibitor patients with prior prophylaxis or on-demand treatment. Efanesoctocog alfa Q1W was also associated with a significantly better improvement from baseline in HJHS Joint Score (mean difference [95% CI] -2.06 [-3.97; -0.14]) and Total Score (-2.37 [-4.36; -0.39]) versus emicizumab Q1W or every 2 weeks.

CONCLUSION:

Efanesoctocog alfa prophylaxis was associated with significantly lower rates of any, treated, and joint bleeds and improved joint health compared with emicizumab in patients with severe haemophilia A.

News (Medical) associated with Efanesoctocog alfa

28 Feb 2025

·pmlive.com

Rare Disease Day 2025 – highlighting recent approvals in the rare disease space

Around the world, events are being held to mark Rare Disease Day (28 February 2025), with the aim of bringing attention to rare diseases and improving access to diagnosis and therapies for patients. There are more than 7,000 known rare diseases that impact an estimated 300 million people globally, yet the lack of scientific knowledge and quality information on rare diseases often results in a delay in diagnosis, and treatment options are only available for a small proportion of rare diseases. Significant progress is, however, continually being made in the rare disease space. Just last week, the US Food and Drug Administration (FDA) approved Mirum Pharmaceuticals’ Ctexli (chenodiol) for adults with cerebrotendinous xanthomatosis (CTX), making it the first treatment to be approved by the regulator for the rare lipid storage disease. Affecting up to 2,000 people in the US, CTX is a progressive genetic disorder caused by a deficiency of an enzyme that allows the body to break down fats. This results in the deposition of atypical cholesterol metabolites in the brain and other areas of the body. Mirum’s chief executive officer, Chris Peetz, described the approval as “tremendous”, noting that it “unlocks an opportunity to better identify and treat adult patients with CTX in the US”. Gilead Sciences’ seladelpar was also granted conditional marketing authorisation by the European Commission (EC) last week to treat patients with the rare liver disease primary biliary cholangitis (PBC). Approximately 163,000 people in Europe are affected by PBC, an autoimmune disease of the bile ducts that disproportionally affects women. Timothy Watkins, vice president, clinical development of inflammation therapeutics at Gilead, said at the time of the announcement: “People living with PBC in Europe have been waiting for treatment advancements for many years. “Up until now, there has been no approved treatment for PBC addressing both the surrogate biomarkers for underlying disease and pruritus, a common and at times debilitating symptom of PBC.” Merck & Co’s – known as MSD outside the US and Canada – Welireg (belzutifan) was conditionally approved by the EC last week to treat certain patients with von Hippel-Lindau disease, a rare tumour-causing genetic disorder affecting up to 15,000 people in Europe. Sobi’s Sanofi-partnered efanesoctocog alfa also recently received approval by the Medicines and Healthcare products Regulatory Agency to treat the rare bleeding disorder haemophilia A, while SpringWorks Therapeutics’ Gomekli (mirdametinib) was approved by the FDA earlier this month to treat neurofibromatosis type 1, a rare genetic disorder that causes a variety of symptoms across multiple organ systems. Since being established in 2008 by the European Organisation for Rare Diseases, Rare Disease Day has played a critical role in building an international rare disease community and has seen a significant increase in events and campaigns across the world, with patient organisations, medical professionals and research institutions uniting to drive progress in rare disease research and advocacy.

Drug Approval

17 Feb 2025

·pmlive.com

Sobi receives MHRA approval for Altuvoct in severe or moderate haemophilia A

Sobi’s Sanofi-partnered efanesoctocog alfa has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A. The drug has been authorised under the brand name Altuvoct to treat and prevent bleeding in patients aged two years and older with severe or moderate cases of the genetic bleeding disorder. Haemophilia is a rare condition resulting from insufficient levels of functioning factor VIII, a protein that is essential for blood clotting. Patients can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. The active substance in Altuvoct, which is administered as an intravenous injection, replaces the missing factor VIII, helping the blood to clot and providing temporary control of the disorder. The MHRA’s decision on the drug was based on results from the late-stage XTEND-1 study of 159 patients aged 12 years and older with severe haemophilia A. Weekly injections of Altuvoct led to 65% of patients reporting zero overall bleeding episodes over the course of the year-long study, while the remaining 35% saw significant reductions in bleeding episodes. Also supporting the regulator’s decision were positive results from the phase 3 XTEND-Kids trial of 74 children aged under 12 years with severe haemophilia A, as well as data from a modelling exercise of those with moderate cases of the disease. Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Patient safety is our top priority, which is why I am pleased to confirm approval of [Altuvoct] to treat and prevent bleeding in patients two years and above with severe or moderate haemophilia A. “We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.” Sanofi and Sobi collaborate on the development and commercialisation of efanesoctocog alfa in the US, where it is marketed as Altuviiio, while Sobi has final development and commercialisation rights in Europe, North Africa, Russia and most Middle Eastern markets, with Sanofi holding these rights in North America and all other regions worldwide, excluding the Sobi territory.

Clinical ResultDrug ApprovalPhase 3

30 Jan 2025

·www.globenewswire.com

Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025

Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 Paris, January 30, 2025 Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31 Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIODupixent sales up 16.0% to €3.5 billionVaccines sales up 10.8% to €2.2 billion, driven by Beyfortus sales in EuropeBusiness EPS of €1.31, -11.0% at CER and -14.9% reported; IFRS EPS of €0.54 FY: double-digit sales growth and business EPS guidance exceeded Sales totaled €41.1 billion, an increase of 11.3% at CERSales targets exceeded: Dupixent >€13 billion and Beyfortus blockbuster status (€1.7 billion) in its first full yearResearch and Development expenses reached €7.4 billion, up 14.6%, in line with commitmentsBusiness EPS of €7.12, +4.1% at CER, above guidance, and -1.8% reported; IFRS EPS of €4.59The Board of Directors met on January 29, 2025; proposes a dividend of €3.92 for 2024, 30th year of consecutive increases Pipeline: increased investment and progress Q4: four regulatory approvals: Dupixent EoE (children) (EU), Kevzara PMR (EU), Cerdelga GD1 (children) (EU), Efluelda flu (JP)3FY: 14 regulatory approvals of medicines and vaccines, 21 regulatory submission acceptances, and eight positive phase 3 readouts emphasize a positive and improving pipeline momentum Further progress towards a focused biopharma business Intention to sell a controlling stake in Opella consumer health at an attractive valuation; closing in Q2 2025 at the earliest4 Guidance In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback).6Sanofi intends to execute a share buyback program in 2025 of €5 billion. Shares will be purchased preferably through block trades and in the open market with the purpose of cancellation. Paul Hudson, Chief Executive Officer: “We achieved double-digit sales growth in 2024 while pursuing the transformation of the company. Innovation was a key driver of our growth as launches already contributed 11 percent of sales, with Beyfortus becoming a blockbuster in its first full year of sales. We exceeded our business EPS guidance. In 2024, we announced an intention to sell a controlling stake in Opella consumer health, which will make Sanofi a focused, science-driven biopharma company. We increased R&D investments and achieved significant progress with our pipeline in 2024, including positive phase 3 study results for new medicines such as rilzabrutinib in rare diseases and tolebrutinib in multiple sclerosis. As we enter 2025, we expect continued, solid growth in sales and a strong rebound in earnings. We are also confident in the mid to long-term growth prospects of Sanofi, supported by ongoing launches, Dupixent (currently expected to reach sales of around €22 billion in 20307, in line with the current ambition), and expected future launches from our pipeline.” Q4 2024 Change Change at CER FY 2024 Change Change at CER IFRS net sales reported €10,564m +9.1% +10.3% €41,081m +8.6% +11.3% IFRS net income reported €683m — — €5,744m +6.4% — IFRS EPS reported €0.54 — — €4.59 +6.5% — Free cash flow8 €2,340m -25.5% — €5,955m -19.6% — Business operating income €2,078m -11.8% -7.7 % €11,343m +1.5% +7.6% Business net income €1,642m -15.1% -11.2 % €8,912m -1.8% +4.1% Business EPS €1.31 -14.9% -11.0% €7.12 -1.8% +4.1% 1 Changes in net sales are at constant exchange rates (CER) unless stated otherwise (definition in Appendix 9).2 To facilitate an understanding of operational performance, Sanofi comments on the business net income statement which is a non-IFRS financial measure (definition in Appendix 9). The income statement is in Appendix 3 and a reconciliation of reported IFRS to business net income is in Appendix 4.3 For the definition of medical and scientific terms, please see the first use of the word in the Pipeline update section.4 Subject to finalization of definitive agreements and subject to obtaining regulatory approvals from the competent authorities.5 In 2025, sales growth will exclude any impact from hyperinflation. In 2024, it is estimated that sales growth benefited by 1.8 percentage points.6 Applying average January 2025 exchange rates, the currency impacts are estimated between +2% and +3% on sales and +2% and +3% on business EPS.7 At CER.8 Free cash flow is a non-IFRS financial measure (definition in Appendix 9). Attachment Press_Release

Phase 3Clinical ResultFinancial StatementBiosimilarDrug Approval

100 Deals associated with Efanesoctocog alfa

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemophilia A	US	Bioverativ, Inc.	22 Feb 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	US	Sanofi (China) Investment Co. Ltd.	23 Feb 2021
Hemorrhage	Phase 3	US	Biogen, Inc.	23 Feb 2021
Hemorrhage	Phase 3	US	Bioverativ Therapeutics, Inc.	23 Feb 2021
Hemorrhage	Phase 3	BE	Sanofi (China) Investment Co. Ltd.	23 Feb 2021
Hemorrhage	Phase 3	BE	Bioverativ Therapeutics, Inc.	23 Feb 2021
Hemorrhage	Phase 3	BE	Biogen, Inc.	23 Feb 2021
Hemorrhage	Phase 3	BG	Bioverativ Therapeutics, Inc.	23 Feb 2021
Hemorrhage	Phase 3	BG	Sanofi (China) Investment Co. Ltd.	23 Feb 2021
Hemorrhage	Phase 3	BG	Biogen, Inc.	23 Feb 2021
Hemorrhage	Phase 3	CA	Bioverativ Therapeutics, Inc.	23 Feb 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04161495 (XTEND-1, Pubmed \| Clin Ther)	Phase 3	Hemophilia A	159	Efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks	nnyovwscmg(duaccyghmy) = kmwnnnrzua nbrimceezm (iswpfuqvqf ) View more	Positive	01 Dec 2024
NCT04759131 (XTEND-Kids, PRNewswire) Manual	Phase 3	Hemophilia A	73	ALTUVOCT	djnanotqtj(tvubhjlvgw) = tztocaoxzn fsrkmktumu (zqgpqdtyma, 0.42–0.90) View more	Positive	18 Jul 2024
NCT04759131 (XTEND-Kids, Pubmed)	Phase 3	Hemophilia A	74	Efanesoctocog alfa	hmnmplvdnz(uxbydxfoxt) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. wnuqyzpwce (hikcddejun )	Positive	18 Jul 2024
NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) Manual	Phase 1	Hemophilia A FVIII	13	Octocog alfa	lopwdlbwmf(luxaclyspx) = ncgvxitmfi cjlpmwtygz (slkwviavhh ) View more	Positive	14 May 2024
	Phase 1	Hemophilia A FVIII	13	Rurioctocog alfa pegol	lopwdlbwmf(luxaclyspx) = bjgriqgecq cjlpmwtygz (slkwviavhh ) View more	Positive	14 May 2024
NCT04759131 (XTEND-Kids, CTgov)	Phase 3	Hemophilia A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged <6 Years)	ythditvgqb(afszmyqtog) = mzhxyaquig dooqhyrmxp (dgtgadkzbd, inuynldrjc - fgidiqnvtq) View more	-	13 Feb 2024
NCT04759131 (XTEND-Kids, CTgov)	Phase 3	Hemophilia A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged 6 to <12 Years)	ythditvgqb(afszmyqtog) = exkcpkglyv dooqhyrmxp (dgtgadkzbd, jbopnaslgk - bartxqmrhy) View more	-	13 Feb 2024
NCT04161495 (XTEND-1, ISTH2023)	Phase 3	Hemophilia A	78	Standard-of-care FVIII prophylaxis	dpxszyacmd(ahrorccveq) = dodhakvjen olanfdypxe (szyhwifhek )	-	24 Jun 2023
NCT04161495 (XTEND-1, ISTH2023)	Phase 3	Hemophilia A	78	Efanesoctocog alfa 50 IU/kg prophylaxis	dpxszyacmd(ahrorccveq) = qvdahtqtpe olanfdypxe (szyhwifhek )	-	24 Jun 2023
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) Manual	Phase 3	Hemophilia A	159	Efanesoctocog alfa	jezcdzbvzb(tzrgulxwgh) = feqohmamjb phwcztfgyy (bpmrhyqkqm ) View more	Positive	15 Nov 2022
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) Manual	Phase 3	Pain \| Hemophilia A	159	Efanesoctocog alfa (Arm A)	vxbflgmxmg(ubeysxklzf) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 itrkpwyagr (zxuwahkqgj )	Positive	15 Nov 2022
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) Manual	Phase 3	Pain \| Hemophilia A	159	Efanesoctocog alfa (Arm B)		Positive	15 Nov 2022
NCT04161495 (XTEND-1, Corporate Publications) Manual	Phase 3	Hemorrhage	150	Efanesoctocog alfa	oivqkdeced(sqekzqbizd) = ncahjmjmbq jqeeepzehz (sglfwyffhx )	Positive	11 Jul 2022
NCT04161495 (XTEND-1, ISTH2022)	Phase 3	Hemophilia A	217	Efanesoctocog Alfa (BIVV001)	autywmofnd(djazlfbduu) = gxpviolbfn gkqlzuahlf (lqnldlwpyu )	-	09 Jul 2022

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