Bayer's Kovaltry Receives NMPA Approval for Hemophilia A Treatment in China

German pharmaceutical giant Bayer recently announced that Kovaltry, a new drug for hemophilia A, has been approved by China's National Medical Products Administration (NMPA) for routine prophylactic treatment, on-demand treatment, and management of perioperative bleeding events in pediatric and adult patients with hemophilia A. Kovaltry is an unmodified, full-length recombinant coagulation factor VIII product. In clinical trials, prophylactic administration two or three times per week effectively controlled and prevented bleeding episodes in patients with hemophilia A.

Dr. Joerg Moeller, Member of the Executive Committee of Bayer HealthCare and Global Head of Research and Development, stated, “We are delighted that Kovaltry has been approved by Chinese regulatory authorities. Children and adults with hemophilia A in China will soon have access to this new product, which will help improve patients’ quality of life. The proven efficacy and safety profile of Kovaltry offer a flexible treatment approach tailored to the individual needs of patients with hemophilia A.”

Currently, Kovaltry has been approved in numerous countries and regions worldwide, including the United States, Europe, and Japan. The approval of Kovaltry is based on positive data from the LEOPOLD (Long-term Efficacy Open-label Program in Hemophilia A) clinical development program, which comprises three international, multicenter clinical studies (LEOPOLD I, LEOPOLD II, and LEOPOLD Kids). The relevant data have confirmed the efficacy and safety of Kovaltry for routine prophylactic treatment, on-demand treatment of bleeding episodes, and perioperative bleeding management in children, adolescents, and adults with severe hemophilia A (<1% FVIII:C).

Hemophilia is an inherited bleeding disorder affecting approximately 400,000 people worldwide. It results from the inability to produce sufficient clotting factors to ensure effective hemostasis, leading to recurrent bleeding into muscles and major organs. There are two main types of hemophilia: Hemophilia A and Hemophilia B. Hemophilia A is caused by a deficiency or defect in clotting factor VIII, whereas Hemophilia B is caused by a deficiency or defect in clotting factor IX.

Hemophilia A, also known as classic hemophilia, is characterized by recurrent persistent or spontaneous bleeding episodes, particularly in the joints, muscles, or internal organs, if not adequately treated. Long-term consequences can lead to disability in patients. As Hemophilia A is an X-linked recessive genetic disorder, it predominantly affects males. The estimated incidence rate among males is approximately 1 in 5,000. In China, there are approximately 12,500 patients with Hemophilia A.

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