FDA approves Kovaltry (recombinant Factor VIII), for the treatment of hemophilia A- Bayer Health Care
The FDA has approved Bayer’s Kovaltry (recombinant Factor VIII), for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD clinical trials*, which supported the approval of Kovaltry for routine prophylaxis to reduce the frequency of bleeding episodes. The most frequently reported adverse reactions in the clinical trials (at least 3%) were headache, pyrexia (fever), and pruritus (itchy rash). Kovaltry can be used two or three times per week in adolescents and adults, and two or three times per week or every other day in children.
Comment: Earlier this year, Bayer received approval of Kovaltry in Europe and Canada. The company has submitted an application for approval of Kovaltry in Japan, and plans to file for approval in other countries in the coming months.
Comment: Kovaltry is set to eventually replace Bayer’s marketed rFVIII (Kogenate). It has the same product expression construct and primary amino acid sequence as for Bayer’s marketed rFVIII with superior glycosylation (branching, sialylation capping).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins