Baxter Submits Application for FDA Approval of FEIBA NF for Prophylactic Use in Hemophilia A and B Patients with Inhibitors Business Wire DEERFIELD, Ill. -- February 26, 2013 Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors. As many as one third of people with hemophilia develop an inhibitor to factor replacement used to treat or prevent bleeding episodes. The presence of an inhibitor makes response to treatment more challenging, and patients with inhibitors have an increased risk of developing complications such as joint damage. It is estimated that approximately 17,000 people in the U.S. have been diagnosed with hemophilia A or B.^1 ''This regulatory submission helps fulfill Baxter’s commitment to advancing care for patients who have developed inhibitors, a serious and sometimes life-threatening complication for those with hemophilia A or B,'' said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter’s BioScience business. ''Baxter has been supporting innovations in care for the hemophilia community for more than 60 years, and our work continues not only with FEIBA, but also with other treatments we are actively developing.'' Baxter recently shared top-line results from the pivotal Phase III study that formed the basis for the BLA submission. Results from the study demonstrated that routine prophylactic treatment with FEIBA NF reduced median annual bleed rate (ABR) from 28.7 during FEIBA NF on-demand treatment compared to 7.9 during FEIBA NF prophylactic treatment (a 72.5% reduction), with 17 percent (3 of 17) of patients in the intent-to-treat group experiencing zero joint bleeds. The complete results of the Phase III study will be presented at a scientific meeting later this year. The prospective, open label, randomized, multi-center, parallel study investigated the efficacy, safety and health-related quality of life benefits of FEIBA NF prophylactic treatment compared to on-demand treatment in 36 patients with hemophilia A or B and inhibitors over a 12-month period. The most commonly reported adverse reactions in the study were hypersensitivity, dizziness, headache, rash, hypotension and hepatitis B surface antibody positive laboratory test result. The occurrence of hepatitis B surface antibodies has been seen in other plasma-derived products and could be due to the passive transfer of antibodies following FEIBA NF treatment. None of the subjects showed any signs or symptoms of hepatitis B infection. About FEIBA NF FEIBA NF is not indicated for prophylaxis use in the United States. Canada, The Netherlands, Israel, Australia/New Zealand, Japan and South Korea also do not have a prophylaxis indication. Indications for FEIBA NF In the U.S., FEIBA NF [Anti-Inhibitor Coagulant Complex] is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than five Bethesda Units (B.U.) may be successfully treated with Antihemophilic Factor. Patients with titers ranging between five and ten B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor. Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function that were present before treatment with FEIBA NF, nanofiltered and vapor-heated. Detailed Important Risk Information for FEIBA NF Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. The use of FEIBA NF is contraindicated: *In patients who have known anaphylactic or severe hypersensitivity reactions to the product *In patients who are known to have a normal coagulation mechanism *For the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX *In patients with significant signs of disseminated intravascular coagulation (DIC) *In patients with acute thrombosis or embolism (including myocardial infarction) At first sign or symptoms of an infusion/hypersensitivity reaction or a thrombotic/ thromboembolic event, FEIBA NF administration should be stopped immediately and diagnostic and therapeutic measures initiated as appropriate. Allergic-type hypersensitivity reactions, including severe anaphylactoid reactions, have been reported following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension; these reactions can be severe and can be systemic. Many of the reported cases of thromboembolic events occurred with doses above 200 units/kg/day or in patients with other risk factors. Infusion of FEIBA NF should not exceed single dosage of 100 U/kg and daily doses of 200 U/kg of body weight. Patients receiving more than 100 U/kg of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding. FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients at risk of DIC, arterial or venous thrombosis. If clinical signs of intravascular coagulation occur, which include changes in blood pressure, changes in pulse rate, respiratory distress, chest pain and/or cough, infusion of FEIBA NF should be stopped promptly. Non-hemophilic patients with acquired inhibitors against factors VIII, IX or XII may have both a bleeding tendency and an increased risk of thrombosis at the same time. FEIBA NF is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. Adverse reactions reported in clinical studies with FEIBA were anamnestic response, somnolence, dizziness, dysgeusia, dyspnea, hypoesthesia, nausea, chills, pyrexia, chest pain and chest discomfort. For information on FEIBA NF use in the United States, please visit: http://www.baxter.com/healthcare_professionals/products/feiba_nf.html. Licenses and licensing conditions may vary from country to country; therefore please always consult your local full prescribing information. Please check the FEIBA NF website for information on indications approved in other countries. About Hemophilia A Hemophilia is a rare genetic blood clotting disorder that primarily affects males.^2 People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. Two of the most common forms of hemophilia are A and B.^3 In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent.^2 Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.^2 According to the World Federation of Hemophilia, it is estimated that more than 400,000 people in the world have hemophilia.^2 All races and economic groups are affected equally.^1 About Hemophilia B Hemophilia B is the second most common typeof hemophilia (also known as Christmas disease) and is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding.^4 Approximately 26,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B.^5 Hemophilia B is often a debilitating, chronic disease with complications that include bleeding episodes, hemophilic arthropathy (bleeding into a joint) and hospitalization.^6 About Inhibitors As many as one-third of patients with severe or moderately severe hemophilia A are at risk for developing inhibitors, which are antibodies produced by the body’s immune system in response to factor replacement therapy. Inhibitors cause the body to work against the factor replacement therapy, neutralizing its effect and preventing an individual’s blood from clotting.^7 Individuals who have inhibitors have a form of hemophilia that is more difficult to control, with an increased risk of uncontrolled bleeding, compared to patients without inhibitors. Inhibitor development is considered one of the most serious complications associated with hemophilia treatment, and may include other associated complications such as impaired movement, increased need for surgery and greater complexity or risk associated with surgery.^8 About Baxter in Hemophilia Baxter has more than 60 years of experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company’s work is focused on optimizing hemophilia care and improving the lives of people living with hemophilia A and B worldwide. About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. ^1 World Federation of Hemophilia Report on the Annual Global Survey 2011. World Federation of Hemophilia. Accessed on February 19, 2013. Available at: http://www1.wfh.org/publications/files/pdf-1488.pdf ^2 About Bleeding Disorders: Treatment. World Federation of Hemophilia. Accessed on: February 19, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=642 ^3 Frequently Asked Questions About Hemophilia. World Federation of Hemophilia. Accessed on: January 29, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=637 ^4 Frequently Asked Questions About Hemophilia.World Federation of Hemophilia.Accessed on January 29, 2013 Available at: http://www.wfh.org/en/page.aspx?pid=637 ^5 World Federation of Hemophilia Report on the Annual Global Survey 2011. World Federation of Hemophilia. Accessed on February 19, 2013. Available at: http://www1.wfh.org/publications/files/pdf-1488.pdf ^6 Lee, C. A. (2011) Hemophilia Care in the Modern World, in Current and Future Issues in Hemophilia Care (eds E.-C. Rodríguez-Merchán and L. A. Valentino), Wiley-Blackwell, Oxford, UK. Accessed on January 29, 2013. Screen shot of page available here ^7 What are Inhibitors (section)?. World Federation of Hemophilia. Accessed on January 29, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=651. ^8 Leissinger, Cindy A. Prevention of Bleeds in Hemophilia Patients With Inhibitors: Emerging Data and Clinical Direction. American Journal of Hematology. 2004; 77:187-193. Contact: Baxter International Inc. Media Contacts Brian Kyhos, (224) 948-4210 Deborah Spak, (224) 948-2349 or Investor Contacts Mary Kay Ladone, (224) 948-3371 Clare Trachtman, (224) 948-3085
Baxter Submits Application for FDA Approval of FEIBA NF for Prophylactic Use in Hemophilia A and B Patients with Inhibitors
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