The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
The approval is based on results from clinical trials demonstrating 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 company notes in a press release.
The Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease (LEOPOLD) clinical development program consisted of three multinational clinical trials that evaluated the pharmacokinetics, efficacy, and safety of Kovaltry in patients with severe hemophilia A (<1% factor VIII:C). The combined trials evaluated Kovaltry in more than 200 children and adults with severe hemophilia A from 60 sites in 25 countries worldwide, the company said.
Kovaltry was approved by the European Commission on February 22.
Worldwide, hemophilia affects about 400,000 people. Hemophilia A is the most common type, affecting one in 10,000 males, including more than 30,000 in Europe and 16,000 in the United States.
FDA Clears Factor VIII Product Kovaltry for Hemophilia A. Medscape. Mar 17, 2016.