Posted from: Monday, October 08, 2018 - 12:31 PM - Present

Jivi Approved to Treat Hemophilia A

August 30, 2018 – The U.S. FDA has approved Jivi® (antihemophilic factor [recombinant] PEGylated-aucl), manufactured by Bayer, to provide prophylactic, on-demand, and perioperative management of bleeding for adolescents and adults 12 years of age and older who have hemophilia A.

An estimated 20,000 individuals in the United States live with hemophilia A, which is four times more common than hemophilia B. The majority of cases (60%) are classified as severe. These patients may experience frequent spontaneous bleeding episodes caused by a lack of factor VIII, a clotting protein, in their blood.

Jivi is a form of recombinant factor VIII replacement therapy that delivers sustained levels of medication in the blood. Recommended doing is based on weight, and prescribers are advised to initiate treatment with 30–40 IU/kg dosing twice per week to begin. Prescribers can adjust dosing to 45–60 IU/kg every 5 days as needed. They can also raise or lower the frequency of dosing based on an individual patient’s bleeding episodes.

Bayer has already launched the product.

Last Updated Friday, October 19, 2018 - 01:34 AM.