FDA Approves Bayer's Kogenate® FS Antihemophilic Factor VIII (recombinant) for Routine Prophylaxis in Adults with Hemophilia A - Kogenate® FS antihemophilic factor (recombinant) approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A

- Bayer's SPINART study met its primary efficacy and safety objectives for the treatment of adult patients with hemophilia A

WHIPPANY, N.J., May 12, 2014 /PRNewswire/ -- Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer's Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.  The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25 IU/kg three times per week) or on-demand treatment.

"In Bayer's SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment," said Marilyn Manco-Johnson, M.D., Principal Investigator of the study and Director, Mountain States Regional Hemophilia and Thrombosis Center, University of Colorado at Denver and Health Sciences Center. "Such clinical information can help healthcare professionals provide appropriate treatment advice to their patients."

Data from the SPINART Study
The approval is based on data from the SPINART study1, published in the Journal of Thrombosis and Haemostasis, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25 IU/kg three times per week) or on-demand treatment. In the study, patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous six months (≥15 vs. <15 annualized bleeds).  Safety and efficacy results from an analysis of the primary endpoint of bleeding frequency after a median follow-up period of 1.4 years provided the basis for the approval.   The safety objectives were also met.  Adverse events were consistent with the existing safety profile for Kogenate® FS.

As noted in the Prescribing Information, serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.  The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (e.g., rash, pruritus), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) associated infections.

Patients who received prophylaxis experienced significantly fewer bleeds (p<0.0001) compared to patients treated on-demand regardless of baseline subgroups examined including age, bleeding history, and presence or absence of target joints. The ratio of the mean bleeding frequency was 15.2 (95% CI: 8.5, 27.2; p<0.0001) for on-demand versus prophylaxis, indicating that patients who received on-demand treatment experienced on average 15.2 times as many bleeds compared to patients treated with prophylaxis.  The mean annualized bleed rates (bleeds/subject/year) were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate (bleeds/subject/year) in the on-demand group was 33 versus 0 in the prophylaxis group.  Twenty-two of 42 (52%) prophylaxis subjects experienced no bleeding, and 12 of 42 (29%) prophylaxis subjects experienced only 1-2 bleeds during the follow-up period. 

Indications
Kogenate® FS antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Kogenate FS is used to prevent or control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.

Kogenate FS is not used to treat von Willebrand disease.

Important Safety Information
You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.

Your body can make antibodies, called "inhibitors," against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS.

For important risk and use information, please see the full prescribing information.

About SPINART
SPINART (Secondary Prophylaxis in Adults, a Randomized Trial) is an open-label, randomized, parallel-group study of 84 male subjects aged 15 to 50 years with severe hemophilia A (<1% FVIII:C). In this Bayer-sponsored phase III study, subjects were randomized 1:1 to receive Kogenate® FS either as a prophylaxis regimen of 25 IU/kg 3 times per week (n=42) or on-demand, (n=42). Escalation by 5 IU/kg (to 30 or 35 IU/kg maximum) was allowed for subjects with ≥12 annual bleeds after 1 and 2 years. The primary endpoint was bleeding frequency after all patients had completed at least one year of treatment. More information on this trial is available at www.clinicaltrials.gov (NCT00623480).

About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is a largely inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the joints, muscles or internal organs.

About Bayer Hematology
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer Hematology includes an approved treatment for hemophilia A and compounds in development for hemophilia A, sickle cell anemia, and other blood and bleeding disorders. Together, these compounds reflect the company's commitment to research and development in these areas.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for Cardiopulmonary Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

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

Forward-Looking Statement
This news 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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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1 Manco-Johnson MJ, Kempton CL, Reding MT, Lissitchkov T, Goranov S, Gercheva L, Rusen L, Ghinea M, Uscatescu V, Rescia V, Hong W. Randomized, controlled, parallel-group trial of routine prophylaxis versus on-demand treatment with rFVIII-FS in adults with severe hemophilia A (SPINART) [published correction appears in J Thromb Haemost. 2014;12: 119–122.] J Thromb Haemost. 2013;11:1119-1127.

Not Intended for UK Media

SOURCE Bayer HealthCare



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