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Bayer passes US FDA's approval for Jivi for the routine prophylactic treatment of hemophilia A.

M2 EQUITYBITES-September 3, 2018-Bayer passes US FDA's approval for Jivi for the routine prophylactic treatment of hemophilia A

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Health care company Bayer revealed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for Jivi for the routine prophylactic treatment of hemophilia A.

The company said Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) has been approved by the US FDA for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The initial recommended prophylactic regimen for Jivi is twice weekly, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes.

According to the company, Jivi is a recombinant factor VIII (rFVIII) replacement therapy, which replaces the reduced or missing FVIII (a protein needed to form blood clots) in hemophilia A patients. Through its site- specific PEGylation, Jivi has a half-life of 17.9 hours that delivers sustained levels in the blood.

The US FDA approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population based on results from the Phase 2/3 PROTECT VIII trial, a 36-week, Phase 2/3, international, open-label trial conducted in previously treated adults and adolescents 12 years of age or older with severe hemophilia A. The trial demonstrated bleed protection and safety of up to a median of 1.9 years (range of 0-2.6 years). About 126 patients completed the main study.

Additionally, the company has submitted marketing authorisation applications for BAY94-9027 for the treatment of hemophilia A in the EU and Japan.

In hemophilia A, the most common type of hemophilia, blood clotting is impaired as a result of a lack or defect of coagulation factor VIII. Patients therefore repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage.

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Publication:M2 EquityBites (EQB)
Date:Sep 3, 2018
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