FDA Approvals Kovaltry for the Treatment of Hemophilia A

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Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.

On March 17, 2016, FDA granted approval of Bayer’s biologics license application (BLA) for Kovaltry antihemophilic factor VIII (recombinant), a biologic for the treatment of hemophilia A in children and adults. According to Bayer, 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. The drug was also recently approved in Europe and Canada for the treatment of hemophilia A. 

According to a report in Reuters, there is no cure for hemophilia A, which is the most common form of the disease. Patients suffering from the disease can spend up to $300,000 per year on frequent injections of blood clotting proteins. Kovaltry may face some competition, the publication noted, because companies including Baxalta, Shire, Pfizer, Biogen, and Novo Nordisk A/S already have hemophilia drugs on the market.


Bayer has also teamed up with Dimension Therapeutics, a company focused on developing novel, liver-directed gene therapy treatments for rare genetic disorders, to develop a gene-therapy treatment for the hemophilia A. According to Dimension, the companies are involved in preclinical testing for patients with ornithine transcarbamylase deficiency and glycogen storage disease. 

Source: Bayer, FDA