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Kovaltry Approval History

Kovaltry (antihemophilic factor (recombinant)) is a human DNA sequence derived, full length Factor VIII concentrate indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

Hemophilia A is a largely inherited bleeding disorder characterized by missing or reduced factor VIII. It is treated by infusing replacement factor VIII intravenously. The approval of Kovaltry is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which supported the approval of Kovaltry for routine prophylaxis to reduce the frequency of bleeding episodes.

Kovaltry is administered via intravenous infusion up to two or three times per week. The most common side effects reported during clinical trials were headache, fever, and itchy rash.

Development History and FDA Approval Process for Kovaltry

DateArticle
Mar 17, 2016Approval FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A
Mar  4, 2015FDA Accepts Bayer's BLA for Investigational Treatment Option in Hemophilia A

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