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FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A

Pivotal Data Show Prophylaxis Treatment with Kogenate FS Reduces the Risk of Joint Damage and Frequent Bleeds in Children with No Pre-Existing Joint Damage

BERKELEY, Calif., Oct. 10 /PRNewswire/ -- Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage. This important approval provides these patients with the only factor VIII treatment that the FDA has determined safe and effective for routine prophylaxis -- a treatment regimen recommended by the National Hemophilia Foundation's Medical and Scientific Advisory Council (MASAC).(1)

"The FDA approval of Kogenate FS as the first factor VIII treatment product in the U.S. to be used to replenish factor VIII levels in a prophylactic manner marks a significant milestone in the care of patients, especially young children, with hemophilia A," said Craig Kessler, M.D., Georgetown University Hospital and Chair, MASAC. "The results from the pivotal clinical study confirmed that the administration of Kogenate FS to prevent bleeding into the joints was more beneficial to joint health and function than 'on-demand' treatment of acute episodes of joint bleeds."

Dr. Kessler added, "The data justify the consideration of prophylaxis treatment for children with severe and moderate severity hemophilia A, uncomplicated by pre-existing joint damage, to be the medical standard of care. The FDA's recognition that Kogenate FS is an effective prophylactic FVIII replacement product has 'jump started' the standard of hemophilia care in the United States so that it is now on par with other developed countries, especially those in Western and Northern Europe."

The FDA approval of Kogenate(R) FS for routine prophylaxis in children without pre-existing joint damage is based on the clinical data from a multicenter trial in the U.S. that included 65 boys with severe hemophilia A less than 30 months of age at study entry. Study participants were followed for up to 5.5 years. This Joint Outcomes Study (JOS), conducted over a 10-year period, was led by Marilyn J. Manco-Johnson, M.D., Professor of Pediatrics and Associate Professor of Pathology in the Department of Pediatrics, University of Colorado at Denver and Health Science Center, and Director of the Mountain States Regional Hemophilia & Thrombosis Center at the University of Colorado. Key findings from the JOS study, published in the August 9, 2007 issue of The New England Journal of Medicine(2), include:

-- 93 percent of the participants in the routine prophylaxis group showed

normal joint function, in contrast to 55 percent in the episodic group.

-- Kogenate FS prophylaxis treatment was able to preserve the joint even if

the child had less than or equal to two bleeds per index joint.

-- Patients from the prophylaxis group were eight times more likely to have

damage-free joints than those from the episodic group.

-- The prophylaxis group had an 81.5 percent reduction in annual bleeding

frequency compared to the episodic group.

-- Overall, there was an 83 percent reduction in the risk for joint damage

in patients receiving prophylaxis from an early age.

-- Ten percent of the patients treated episodically experienced

life-threatening bleeds compared to zero patients treated


-- The most common adverse events were related to central venous access,

such as catheterization and catheter removal, central line infection and


The study was designed with special emphasis on the "index joints," including the elbow, knee and ankle joints, which are most prone to bleeding in severe hemophilia patients. Joint structural outcomes and functioning were measured at 6 years of age by radiography, magnetic resonance imaging (MRI) and physical exams.

"The value for prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available," said Val Bias, CEO, National Hemophilia Foundation. "Bayer HealthCare's pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients."

This U.S. FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.

"Today's announcement is a milestone in Bayer HealthCare's continuing commitment to advancing the science and treatment for the hemophilia community," said Paul Bedard, Vice President, General Manager, Hematology Business Unit, Bayer HealthCare. "From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients."

About Kogenate(R) FS

Kogenate(R) FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate 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 pre-existing joint damage. The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials (frequency greater than or equal to 4% of patients) were skin-associated hypersensitivity reactions (rash, pruritus, urticaria), inhibitor formation in previously untreated or minimally treated patients, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Kogenate 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.

Please see the full prescribing information for important risk and use information at

About Hemophilia A

Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia.

About Bayer HealthCare LLC

Bayer HealthCare LLC is an affiliate of Bayer HealthCare AG, one of the world's leading, innovative companies in the healthcare and medical products industry based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-looking statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

BAYER, the Bayer Cross and Kogenate are registered trademarks of Bayer.

(C)Bayer HealthCare LLC KN-28-000-208

(1) MASAC Recommendation 179 Concerning Prophylaxis (Regular Administration of Clotting Factor Concentrate to Prevent Bleeding) "MASAC recommends that prophylaxis be considered optimal therapy for individuals with severe hemophilia A and B (factor VIII or Factor IX <1%)." Recommendation approved by MASAC on November 3, 2007, and adopted by the NHF Board of Directors on November 4, 2007.

(2) Manco-Johnson, Marilyn. "Prophylaxis versus Episodic Treatment to Prevent Joint Disease in Boys with Severe Hemophilia," The New England Journal of Medicine. vol. 357:535-544, August 9, 2007.

SOURCE Bayer HealthCare
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