Kovaltry is an unmodified full-length recombinant factor VIII product, which is designed to reduce bleeding in patients with hemophilia A when administered prophylactically two or three times a week.
The approval was based on results from the long-term efficacy open-label program in severe hemophilia A disease (LEOPOLD) clinical trials, comprised of three clinical studies to demonstrate the drug’s pharmacokinetics, efficacy and safety.
In the trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis.
Bayer senior vice president and head of medical affairs for the Americas Dario Mirski said: "Bayer has been committed to providing treatments for hemophilia A for more than 20 years.
"We’re proud to have used that knowledge to develop Kovaltry."
Kovaltry was approved in the Europe and Canada in February this year. Bayer has submitted an application for the drug’s approval in Japan, and intends to file for approval in other countries over the coming months.
Bayer said Kovaltry is not used to treat von Willebrand Disease and the drug should not be used if a patient is allergic to rodents such as mice and hamsters or any of its ingredients.
Haemophilia A is the most common type of the disease characterized by the reduction or absence of factor VIII, affecting about 1 in 10,000 males, including 16,000 in the US currently.
The condition can lead to prolonged or spontaneous bleeding, particularly into the joints, muscles or internal organs.
Image: The FDA approved Bayer’s Kovaltry Antihemophilic Factor (Recombinant). Photo: courtesy of Bayer Corporation.