FDA OKs Bayer’s Hemophilia A Therapy

The US Food and Drug Administration has 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.

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.

Source: Bayer

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