Bayer to Present Results from Head-to-Head PK Comparison Study of Jivi® Versus Adynovate® in Late-Breaker Presentation at the Annual World Federation of Hemophilia Virtual Summit

Bayer announced today it will present new data highlighting the results from the first head-to-head study directly comparing the pharmacokinetic (PK) profiles of two extended half-life (EHL) recombinant factor VIII (FVIII) therapies, Jivi^® (antihemophilic factor [recombinant] PEGylated-aucl) and Adynovate^® (antihemophilic factor [recombinant] PEGylated) in people living with hemophilia A. The data will be presented in an oral presentation during a scientific session at the World Federation of Hemophilia Virtual Summit taking place June 14–June 19, 2020.

“Pharmacokinetics play an important role in determining how a therapy interacts with the body and the subsequent level of protection it provides at different time points throughout the dosing cycle. This information can be useful when selecting or modifying a FVIII treatment strategy for people living with hemophilia A,” said Maria Elisa Mancuso, M.D., Ph.D., the presenting author, Center for Thrombosis and Hemorrhagic Diseases of Humanitas Clinical and Research Center – IRCCS in Rozzano, Milan, Italy. “We look forward to sharing the results from the first study ever comparing the pharmacokinetic characteristics of Jivi versus Adynovate with the hemophilia A community.”

Presentation Details

• Direct Comparison of Two Extended-Half-Life PEGylated Recombinant FVIII Products (Damoctocog alfa pegol and Rurioctocog alfa pegol): A Randomized, Crossover Pharmacokinetic Study in Patients with Severe Hemophilia A
  • Date/Time: Wednesday, June 17, 9:00 a.m. EDT
  • Session: Free Papers: Late-Breaking Medical
  • Location: Virtual
  • Presenter: Maria Mancuso, MD

A medication’s PK profile represents the level of factor in the blood over a certain period of time and is one of several factors physicians and patients should consider when determining the appropriate level of infused FVIII for a patient.¹ EHL recombinant FVIII products usually have improved PK profiles, compared with standard-half-life products, thus have the potential to maintain FVIII levels for longer periods of time.² This enables physicians and patients to tailor the prophylactic regimen based on individual patient needs.

This is the second head-to-head PK comparison study of an extended half-life therapy compared to Jivi since FDA approval in 2018.² In 2019, a head-to-head study directly comparing two EHL rFVIII therapies demonstrated improved PK characteristics for Jivi compared to Eloctate^® (recombinant FVIII fusion protein) in adult patients (n=17) with severe hemophilia A (excluding an outlier patient) who were previously treated with any factor VIII product.² The data were published in the June 14, 2019 issue of Annals of Hematology.

About Jivi (antihemophilic factor [recombinant] PEGylated-aucl)

Jivi is a recombinant factor VIII (rFVIII) replacement therapy, meaning it replaces the reduced or missing FVIII (a protein needed to form blood clots) in patients with hemophilia A.³ Through its site-specific PEGylation, Jivi has a half-life of 17.9 hours that delivers sustained levels in the blood.³

Jivi is approved for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.³ Jivi's initial recommended dosing regimen is twice weekly (30-40 IU/kg) with the ability to dose every five days (45-60 IU/kg) and further individually adjust to less or more frequent dosing based on bleeding episodes.³ The U.S. Food and Drug Administration (FDA) also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.³

Jivi Indications and Important Safety Information

INDICATIONS

• Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
• Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
• Jivi is not for use in children below 12 years of age or in previously untreated patients.
• Jivi is not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION

• You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.
• Tell your healthcare provider about all of your medical conditions that you have or had.
• Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.
• Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.
• Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
• Your body can also make antibodies, called “inhibitors,” against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
• If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
• The common side effects of Jivi are headache, cough, nausea, and fever.
• These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does not go away.

For additional important risk and use information, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Hemophilia A

Hemophilia affects approximately 400,000 people around the world, including an estimated 20,000 in the U.S. today.⁴ It is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced.⁴ In hemophilia A, the most common type of hemophilia, blood clotting is impaired as a result of a lack or defect of coagulation factor VIII.⁴ Patients therefore repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage.⁴

Hemophilia treatment has advanced considerably over the past decades, with life expectancy for people with hemophilia significantly increasing from about 11.4 years in 1920 to a potentially normal life span today.⁵

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. Ahmed TA. Pharmacokinetics of drugs following IV bolus, IV infusion, and oral administration. In: Ahmed TA, ed. Basic Pharmacokinetic Concepts and Some Clinical Applications. Rijeka, Croatia: InTech; 2015.
2. Shah et al. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Annals of Hematology. 2019; 98: 2035–2044.
3. Jivi^® [prescribing information]. Whippany, NJ: Bayer; 2018.
4. National Hemophilia Foundation. Fast Facts. Accessed October 19, 2017. https://www.hemophilia.org/About-Us/Fast-Facts
5. Tom A. Hemophilia and Aging. National Hemophilia Foundation. 2014; 1-6.

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