Bayer’s New FDA Approves Antihemophilic Factor for Hemophilia A


Bayer’s KOVALTRY®– an unmodified, full-length recombinant antihemophilic factor VIII received US Food And Drug Administration (FDA) approval for treatment of hemophilia A in children and adults. 

Hemophilia A is a genetic deficiency in clotting factor VIII which causes profuse bleeding. It leads to the risk of prolonged bleeding from common injuries. Muscle and joint hemorrhages are other symptoms of hemophilia.

According to the clinical trials LEOPOLD (Long Term Efficacy Open-Label Program in Severe hemophillia  A disease), KOVALTRY® showed controlled bleeding and reduced frequency of bleeding episodes with regular dosage of two to three times a week in children and adults with hemophilia A. The LEOPOLD included three multinational clinical trials which enrolled more than 200 children and adults with severe hemophilia A from 25 countries for the evaluation of pharmacokinetics, efficacy and safety profile of KOVALTRY®.

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 Dr. Jörg Möller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “At Bayer we have been developing and producing treatments for hemophilia A for more than two decades.”

Bayer is not any newcomer in the hematology field. It already has KOGENATE, currently available in the market of more than 70 countries and a pipeline candidate long-acting recombinant factor VIII to its credit. Bayer is also looking for alternative treatment approaches in preclinical and early clinical development like factor VIII gene therapy and inhibition of tissue factor pathway inhibitor (TFPI) in hemophilia, and in other blood disorders. Lately, Bayer’s KOVALTRY® also got approved in Europe and Canada.

KOVALTRY® also known as BAY81-8973 is a plasma protein- free version of Bayer’s KOGENATE FS, a recombinant Factor VIII (rFVIII) formulated with sucrose.

Now stay with us and see whether Bayer gets the regulatory approval of KOVALTRY® for hemophilia A treatment in further markets worldwide.

Featured image credit: Blue Blood © plrang (Stock Photo ID: 107289377)

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