FDA approves Bayer hemophilia A drug

March 30, 2016

FDA recently approved antihemophilic factor VIII (recombinant) (Kovaltry, Bayer) for the treatment of hemophilia A in children and adults.

FDA recently approved antihemophilic factor VIII (recombinant) (Kovaltry, Bayer) for the treatment of hemophilia A in children and adults.

Kovaltry is an unmodified, full-length recombinant factor VIII product.

Related: FDA OKs modified antihemophilic factor for hemophilia A

Bayer also recently received approval of Kovaltry in Europe and Canada, and is pursuing regulatory approvals of Kovaltry for the treatment of hemophilia A in other global markets. 

“We are proud that, based on our comprehensive development program, physicians can now consider twice-weekly prophylactic treatment with Kovaltry among the treatment options," said Joerg Moeller, MD, member of the executive committee of Bayer AG's Pharmaceutical Division and Head of Development.

Kovaltry’s US 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 2 or 3 times per week. 

Related: 6 facts about the new hemophilia B drug

Bayer’s 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.

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