Jivi FDA approval : German pharma company Bayer has bagged the US Food and Drug Administration (FDA) approval for its recombinant factor VIII (rFVIII) replacement therapy Jivi (BAY94-9027) as routine preventative treatment of hemophilia A.
The approval of the Bayer hematology drug for hemophilia A treatment covers both adults and adolescents, aged 12 years or older. Jivi is now the third drug of Bayer to be approved by the FDA for hemophilia A treatment after Kogenate and Kovaltry.
The rFVIII replacement therapy has also been approved by the FDA for on-demand treatment and the perioperative management of bleeding in the same patient population.
Bayer said that the initial recommended prophylactic regimen for Jivi is weekly two times with the ability to dose once in five days and further individually adjust to less or more frequent dosing depending upon bleeding episodes.
Bayer hematology drug Jivi FDA approval for hemophilia A treatment
Jivi FDA approval for hemophilia A treatment has been driven by the findings of a phase 2/3 PROTECT VIII trial in which the Bayer hematology drug was shown to deliver bleed protection and safety of up to a median of 1.9 years, said the German pharma company.
Hemophilia A is a genetic deficiency in functional plasma clotting factor VIII. People having this blood disorder find that their blood does not easily clot. The Bayer hematology drug functions by replacing the reduced or missing factor VIII in the affected hemophilia A.
Mark Reding – PROTECT VIII Lead Investigator and Associate Professor of Medicine at the University of Minnesota, commenting on Jivi FDA approval for hemophilia A treatment, said: “As a physician who treats hemophilia A patients with a range of individualized needs, Jivi’s approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients.
“Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles.”
Jivi, through its site-specific PEGylation, has a half-life of 17.9 hours that produces sustained levels in the blood.
Carsten Brunn – President of Bayer Pharmaceuticals, Americas Region, commenting on Jivi FDA approval for hemophilia A treatment, said: “Today’s approval builds on our 25-year partnership with the hemophilia community and underscores our commitment to developing new therapies that help meet the needs of patients living with this life-long disease.
“Jivi’s proven efficacy with its unique dosing regimen is an important benefit to patients that we look forward to bringing to the global community, as we pursue additional regulatory approvals for Jivi in other regions around the world.”
Bayer is also seeking approvals for BAY94-9027 for hemophilia A treatment in the European Union and Japan having submitted marketing authorization applications.
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