Efanesoctocog alfa is a Fusion Protein owned by Sanofi, and is involved in 6 clinical trials, of which 3 were completed, 2 are ongoing, and 1 is planned.

Efanesoctocog alfa acts as coagulation factor VIII replacement therapy. Hemophilia is caused by the failure to produce certain proteins required for blood clotting, factor VIII (hemophilia A). In response to injury, coagulation factor VIII is activated and separates from von Willebrand factor. Factor VIII is a co-factor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. The drug candidate is a recombinant factor VIII fusion protein which replaces the deficient coagualnt factor VIII and facilitates in effective hemostasis.

The revenue for Efanesoctocog alfa is expected to reach a total of $23.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Efanesoctocog alfa NPV Report.

Efanesoctocog alfa was originated by Amunix Operating and is currently owned by Sanofi. Swedish Orphan Biovitrum is the other company associated in development or marketing of Efanesoctocog alfa.

Efanesoctocog alfa Overview

Efanesoctocog alfa (BIVV-001) (rFVIIIFc-XTEN-vWF fusion molecule) is under development for the treatment of hemophilia A and Von Willebrand's Disease. FVIII is a glycoprotein procofactor. The drug candidate is administered through intravenous route. The drug candidate is a recombinant coagulation factor VIII Fc-Von Willebrand factor-XTEN fusion protein. It is developed based on XTEN technology. BIVV-001 acts by targeting coagulation factor VIII.

Sanofi Overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

The company reported revenues of (Euro) EUR39,175 million for the fiscal year ended December 2021 (FY2021), an increase of 4.8% over FY2020. In FY2021, the company’s operating margin was 20.7%, compared to an operating margin of 37.8% in FY2020. In FY2021, the company recorded a net margin of 15.9%, compared to a net margin of 32.9% in FY2020. The company reported revenues of EUR13,138 million for the third quarter ended September 2022, a decrease of 36.8% over the previous quarter.

Quick View – Efanesoctocog alfa

Report Segments
  • Innovator
Drug Name
  • Efanesoctocog alfa
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
Key Companies
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.