This article is more than 5 years old. Information may no longer be current.
FDA approves Kovaltry for hemophilia A
Click Here to Manage Email Alerts
The FDA approved antihemophilic factor (recombinant) for the treatment of children and adults with hemophilia A, according to a press release from the agent’s manufacturer.
Antihemophilic factor (recombinant) [Kovaltry, Bayer] — an unmodified, full-length Factor VIII compound — can be used two to three times per week in adolescents and adults, or two to three times per week or every other day in children.
The FDA based the approval on results from the LEOPOD clinical program, a series of three multicenter, open-label trials.
Results showed the agent could be used safely and effectively for routine prophylaxis to reduce bleeding episodes in patients with severe hemophilia A.
The most common adverse reactions among Kovaltry-treated patients included headache, pyrexia and pruritus.
Hemophilia A — also called Factor VIII deficiency — is the most common type of hemophilia. The condition, which affects an estimated 16,000 people in the United States, is an inherited bleeding disorder in which the proteins necessary to form blood clots are missing or reduced.
“Hemophilia care has changed significantly in recent years, but we have a long way to go to help those living with hemophilia,” Val Bias, CEO of the National Hemophilia Foundation, said in a press release. “It is vitally important that people are able to choose from a range of treatments, and we applaud Bayer for bringing forth new product options to help people manage their disease.”