Bayer Receives FDA Approval for Kovaltry® for the Treatment of Children and Adults with Hemophilia A
The U.S. Food and Drug Administration today approved Bayer’s Kovaltry® antihemophilic factor VIII (recombinant) for the treatment of hemophilia A in children and adults. Kovaltry is an unmodified, full-length recombinant factor VIII product. The approval is based on results from the LEOPOLD clinical trials, which demonstrated that Kovaltry controls bleeds, and reduces frequency of bleeding episodes with routine prophylaxis in children and adults with hemophilia A when used two or three times per week.
Bayer recently received approval of Kovaltry in Europe and Canada. Bayer is pursuing regulatory approvals of Kovaltry for the treatment of hemophilia A in further markets across the world.
The approvals of Kovaltry build upon Bayer’s growing hematology portfolio which also includes Kogenate® Bayer, a product currently on the market in more than 70 countries, as well as a long-acting recombinant factor VIII pipeline candidate. Bayer is also pursuing alternative treatment approaches in preclinical and early clinical development, such as factor VIII gene therapy and inhibition of tissue factor pathway inhibitor (TFPI) in hemophilia, as well as in other blood disorders.
The approvals of Kovaltry build upon Bayer’s growing hematology portfolio which also includes Kogenate® Bayer, a product currently on the market in more than 70 countries, as well as a long-acting recombinant factor VIII pipeline candidate. Bayer is also pursuing alternative treatment approaches in preclinical and early clinical development, such as factor VIII gene therapy and inhibition of tissue factor pathway inhibitor (TFPI) in hemophilia, as well as in other blood disorders.
