FDA approval for new hemophilia A treatment, Jivi

30 August 2018

There was positive news today for Germany’s largest pharma company, with approval for its latest hemophilia A drug in the USA, which hopefully will provide a near term boost to its hemophilia portfolio.

The US Food and Drug Administration (FDA) has approved Bayer’s (BAYN: DE) Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The Biologics License Application was filed with the agency in October last year.

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. The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population.

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