Aug 17 2009
CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage.
This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
“The FDA’s approval of this additional indication for Helixate FS will significantly benefit the bleeding disorders community,” said Garrett E. Bergman, M.D. Senior Director of Medical Affairs, U.S. Commercial Operations at CSL Behring. “Prophylactic treatment will reduce the frequency of bleeding episodes in children with hemophilia A which, over time, will help prevent additional joint damage caused by bleeds.”
"Bleeding into joints, including the ankles, elbows and knees, is a concern for children with hemophilia A and their treatment providers," said Jerry S. Powell, M.D., Director of the Hemophilia Treatment Center at the University of California, Davis. "The FDA's approval of Helixate FS for routine prophylaxis is an innovation that will help our patient population effectively manage their condition. Modern treatment of hemophilia means preventing bleeding through routine prophylaxis, and we eagerly anticipate our patients reaching young adulthood with minimal joint damage and the ability to pursue normal lives."
With more than 2.5 billion units infused to date, Helixate FS has been shown to be safe and effective in clinical studies as well as in post marketing use in the hemophilia community. For more information about Helixate FS, please visit www.HelixateFS.com or call CSL Behring Consumer Affairs at 1-888-508-6978.
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 15,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or factor IX. The most common form of the disease is hemophilia A, or classical hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About Helixate FS
Helixate FS is a recombinant factor VIII product indicated to control and prevent bleeding episodes in adults and children with hemophilia A. Helixate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
The most serious adverse reactions with Helixate FS are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Helixate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
Helixate FS offers convenient administration with a 2.5-mL volume diluent for most assay sizes; no available factor VIII product has a smaller diluent size. No albumin is used in the formulation or purification of Helixate FS, and its manufacture includes a solvent/detergent viral inactivation step.
In 2006, the FDA gave approval for Helixate FS to be stored at room temperature (up to 25°C, 77°F) for three months. The storage guidelines for the hemophilia treatment provide users with greater flexibility and simplify storage options.
Helixate® FS is manufactured by Bayer HealthCare LLC for CSL Behring LLC.