FDA approves expanded application of Jivi to benefit children over 7 years old with hemophilia A

Recently, Bayer announced that the U.S. Food and Drug Administration (FDA) has officially expanded the scope of Jivi (antihemophilic factor[ pan>Recombinant], Pegylated-aucl) are applicable to pediatric patients 7 years old and above who have received treatment. This change makes Jivi not only suitable for adult patients with hemophilia A, but also provides an effective treatment option for younger pediatric patients. Jivi is a concentrated preparation of coagulation factor VIII based on recombinant DNA technology, initially released in 2018

The basis for this FDA expansion of approval mainly comes from two important clinical studies-Alfa-PROTECT and PROTECT Kids. Alfa-PROTECTThe study included 35names7 to 12children with severe hemophiliaA aimed to evaluate the safety and effectiveness ofJivi for preventing and treating bleeding events. The study looked specifically at immune responses 4days before infusion, including sensitivity to the polyethylene glycol (PEG) in the drug and the potential risk of acute allergic reactions and drug failure. During the study, patients received at least 50 twice-daily prophylactic treatments with Jivi for 26 weeks, and most patients continued to be observed in subsequent extension studies. The PROTECT Kids study focused on the pharmacokinetic performance and efficacy of 12 children under the age of and collected data from 73 patients to ensure the safe use of Jivi in this population.

Clinical data shows that children aged 7 to 12 have achieved significant results through Jivi treatment. In terms of on-demand treatment, about 97% of bleeding events can be effectively controlled by 1 to 2 infusions. Perioperative management also performed well, with 77 patients undergoing a total of 10 minor surgeries, most of which were assessed as "good" or "excellent" in terms of hemostasis. In routine preventive treatment, 42 out of 57 pediatric patients received Jivi treatment twice weekly, with a median exposure of more than 50 days. The average annualized bleeding rate (ABR) reported in the studies was only 1.7, and more than 60% of the patients did not experience bleeding events. These data fully demonstrate the good efficacy of Jivi in pediatric patient groups.

In terms of safety, Jivi’s common adverse reactions include headache, fever, cough and abdominal pain. It is important to note that some patients may develop an immune response to polyethylene glycol, manifesting as an acute hypersensitivity reaction or reduced drug efficacy. Therefore, FDA clearly stated that children under 7 are not recommended to be treated with Jivi due to the higher risk of allergies and loss of efficacy. Overall, the new approval scope of Jivi is 7 children with hemophilia A aged and above. It brings more treatment options, marks the progress of treatment in this field, and also provides a richer reference for clinical treatment options.

References: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 (congenital factor VIII deficiency). News release. Bayer. May 19, 2025.