U.S. FDA Grants Approval for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl) in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A

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WHIPPANY, N.J.--(BUSINESS WIRE) May 19, 2025 --Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency).

The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. This significant milestone reflects Bayer’s ongoing commitment to providing effective treatment options for the hemophilia community.

Jivi was first granted approval by the FDA in August 2018 for use in previously treated adults 12 years of age and older with hemophilia A for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes.

    • Jivi is not indicated for use in:

  • Children <7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy.
  • Previously untreated patients (PUPs).
  • Treatment of von Willebrand disease.

    • "Bayer remains dedicated to meeting the needs of the hemophilia A community," stated Jessica Charlet, Scientific Director. “The FDA’s approval for pediatric patients 7 to <12 years of age is reflective of Bayer’s commitment to the hemophilia A community and underscores our commitment to supporting families through their treatment journey.”

    Bayer continues to prioritize support for the hemophilia community, and we are excited to offer Jivi as a treatment option for patients and their families.

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

    Jivi is approved for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients 7 years of age or older. Jivi’s initial recommended dosing for children 7 to under 12 years of age is 60 IU/kg twice weekly. Adjust the dose based on the patient’s clinical response and/or recovery. The recommended initial dosage regimen for adults and adolescents is (30-40 IU/kg) twice weekly 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. Jivi is also approved for on-demand treatment and the perioperative management of bleeding in the same population.1 To learn more about Jivi, visit www.jivi.com.

    INDICATION

  • JIVI ® is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for:
  • On-demand treatment and control of bleeding episodes.
  • Perioperative management of bleeding.
  • Routine prophylaxis to reduce the frequency of bleeding episodes.
  • Limitations of useJIVI is not indicated for use in:
  • Children <7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy.
  • Previously untreated patients (PUPs).
  • Treatment of von Willebrand disease.

    • IMPORTANT SAFETY INFORMATION

  • JIVI is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.
  • Hypersensitivity reactions, including severe allergic reactions, have occurred with JIVI. Monitor patients for hypersensitivity symptoms. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. If hypersensitivity reactions occur, immediately discontinue administration and initiate appropriate treatment.
  • JIVI may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
  • Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG).
  • Neutralizing antibody (inhibitor) formation has occurred following administration of JIVI. Carefully monitor patients for development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody).
  • An immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has occurred with JIVI administration. In the clinical trials, the IgM anti-PEG antibodies disappeared within 4-6 weeks. No immunoglobulin class switching from IgM to IgG has been observed.
  • A low post-infusion Factor VIII level, in absence of detectable Factor VIII inhibitors, may be due to loss of treatment effect related to high titers of anti-PEG IgM antibodies. In these cases, discontinue JIVI and switch patients to a different anti-hemophilic product.
  • A reduced recovery of Factor VIII after start of JIVI treatment may be due to transient low titers of anti-PEG IgM antibodies. In these cases, increase the dose of JIVI until recovery of Factor VIII returns to expected levels.
  • The most common (incidence ≥5%) adverse reactions in clinical trials in previously treated patients (PTPs) ≥7 years of age were headache, fever, cough, and abdominal pain.

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

    About Alfa-PROTECT Study

    A multi-center, prospective, single-arm, study to evaluate the safety of Jivi infusions for prophylaxis and treatment of bleeding in previously treated pediatric patients 7 to <12 years of age with severe hemophilia A. The study evaluated the potential risk of hypersensitivity and loss of drug effect associated with an immune response to polyethylene glycol (PEG) during the first 4 exposure days to Jivi. A total of 35 patients with a median age of 8 years (range: 7 to 11) were enrolled and treated prophylactically for a minimum of 50 EDs and 26 weeks. The patients received a treatment regimen of Jivi twice weekly (40-60 IU/kg) at investigator’s discretion. Thirty-two patients completed the treatment phase and were offered continuation in an 18 month extension study. A key secondary endpoint was the annualized bleed rate (ABR)

    About PROTECT Kids Study

    A multi-center, prospective, single-arm trial to evaluate the pharmacokinetics, safety, and efficacy of Jivi for prophylaxis and treatment of bleeding in previously treated pediatric patients <12 years of age with severe hemophilia A. The primary efficacy endpoint was the annualized bleed rate (ABR).

    About Hemophilia A

    Hemophilia affects approximately 400,000 people around the world and is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced. Hemophilia A is the most common type of hemophilia, in which blood clotting is impaired because there is a lack or defect of coagulation FVIII. Patients repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage over time. Injuries can have severe consequences if not treated appropriately, as the blood clots more slowly in hemophilia patients than in healthy individuals. Based on a study that used data collected on patients receiving care in federally funded hemophilia treatment centers during the period 2012–2018, about 33,000 males in the United States are living with the disorder.2

    About Bayer

    Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros.

    © 2025 BayerBAYER, the Bayer Cross and Jivi are registered trademarks of Bayer.

    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 confirm them to future events or developments.

    References:1. Jivi® [antihemophilic factor (recombinant), PEGylated-aucl] [Prescribing Information]. Whippany, NJ: Bayer 20252. Centers for Disease Control and Prevention. About Hemophilia. Last Reviewed: May 2025. https://www.cdc.gov/hemophilia/about/index.html

    Source: Bayer

    Posted : 2025-05-23 12:00

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