In a major advancement for hemophilia A therapy, Bayer’s recombinant factor VIII (rFVIII) replacement therapy, Jivi (BAY94-9027), has received approval from the U.S. Food and Drug Administration (FDA) for routine preventative treatment in individuals aged 12 years and older. This approval marks Jivi as the third hemophilia A treatment drug from Bayer to gain FDA endorsement, following Kogenate and Kovaltry.

The FDA has not only sanctioned Jivi for routine prophylactic treatment but also for on-demand treatment and perioperative management of bleeding for adults and adolescents with this genetic disorder. Bayer has recommended an initial prophylactic regimen of twice-weekly dosing for Jivi, with the flexibility to adjust to once every five days depending on the patient’s bleeding episodes and individual needs.

The approval was significantly supported by results from the phase 2/3 PROTECT VIII trial, which demonstrated that Jivi effectively delivers prolonged bleed protection and safety, with a median duration of up to 1.9 years. The trial underscored Jivi’s capability in providing sustained bleed control, which is critical for patients with hemophilia A, who lack functional plasma clotting factor VIII and experience challenges with blood clotting.

Mark Reding, the PROTECT VIII Lead Investigator and an Associate Professor of Medicine at the University of Minnesota, highlighted the flexibility of Jivi’s dosing regimen, which allows for adjustments based on individual bleed episodes, thereby offering personalized protection against bleeds—a major concern among patients.

Jivi’s design includes site-specific PEGylation, allowing it to have a half-life of 17.9 hours in the bloodstream, thus maintaining sustained therapeutic levels. This pharmacokinetic profile is essential for ensuring consistent protection from bleeding episodes in hemophilia A patients.

Carsten Brunn, President of Bayer Pharmaceuticals, Americas Region, remarked on the approval as a continuation of Bayer’s 25-year partnership with the hemophilia community, highlighting the company’s ongoing commitment to developing innovative therapies. Bayer anticipates bringing Jivi’s benefits to the global community as it seeks further regulatory approvals in other regions, including the European Union and Japan.

The FDA approval of Jivi represents a significant milestone in hemophilia A treatment, offering a new, effective prophylactic and management option for patients. This approval not only expands Bayer’s portfolio in hemophilia treatment but also enhances the quality of life for patients by allowing more tailored treatment regimens.

The approval of Jivi by the FDA signifies a major progression in the treatment options available for hemophilia A, reflecting ongoing advancements in genetic and protein therapies that aim to address complex disorders like hemophilia A more effectively. Bayer’s continued innovation in this field sets a benchmark for future treatments and provides hope for better disease management strategies.

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