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Title: European Union Approves Remicade (Infliximab) For Treatment Of Ankylosing Spondylitis

"European Union Approves Remicade (Infliximab) For Treatment Of Ankylosing Spondylitis"

First and Only Anti-TNF Agent Approved for Treatment Of This Chronic, Debilitating Inflammatory Disease of the Spinal Column KENILWORTH, NJ -- May 21, 2003 -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission of the European Union (EU) has granted centralized marketing authorization to Remicade® (infliximab) for the treatment of ankylosing spondylitis (AS), a chronic, progressive and debilitating inflammatory disease. Remicade is approved in the EU for the treatment of AS patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. Remicade is the first and only anti-TNF agent approved to treat AS. With this approval, Remicade is the only biologic approved in the EU for treating rheumatoid arthritis (RA); Crohn's disease (CD), a serious gastrointestinal disorder; and AS. The EU approval results in Marketing Authorization with unified labeling that will be valid in all 15 EU member states, as well as Iceland and Norway. "The approval of Remicade in the EU represents a significant advance in the treatment of AS, a serious disease that affects a relatively young group of patients and has a significant impact on quality of life and overall function," said Jurgen Braun, M.D., lead investigator and medical director of Rheumazentrum Ruhrgebiet in Herne, Germany, and professor of rheumatology at the Free University in Berlin, Germany. "Until now available treatment was limited to pain medications and NSAIDS. The positive clinical outcomes demonstrated with Remicade show that treating AS patients with this therapy has a significant and sustained impact on the signs and symptoms of this debilitating disease," he added. Ankylosing spondylitis is characterized by inflammation of the joints in the spine, which causes painful stiffening of the spine, and eventually leads to fusion of the vertebrae, often leaving the back curved and inflexible. In addition, AS can cause inflammation of peripheral and axial joints and tendons. In the young men usually affected by AS, symptoms can vary from severe back pain to loss of motion, deformity and frequently disability. Patients suffering from this condition also often experience severe fatigue, which contributes significantly to their deteriorating quality of life. "With this approval, AS patients have an important treatment alternative for a disease that has limited medical options," said Thomas C. Lauda, executive vice president, Schering-Plough Pharmaceuticals. "Remicade continues to demonstrate its effectiveness in treating serious immune disorders and we are committed to further studying its benefits in order to maximize its value for patients," he added. The EU approval of Remicade for treatment of AS is primarily based on results of a one-year, randomized placebo-controlled multi-center trial with adult patients with active AS. The primary study endpoint was improvement in disease activity of at least 50 percent, as measured by the Bath AS disease activity index (BASDAI). The BASDAI is a comprehensive, self-administered instrument that assesses disease activity on the basis of six questions measuring severity of fatigue, spinal and peripheral joint pain, localized tenderness, and morning stiffness (both qualitative and quantitative). In this study, fifty-seven percent of patients treated with Remicade achieved at least a 50 percent reduction from baseline in their BASDAI score compared to only 9 percent of patients receiving placebo (p < 0.0001). For many patients, improvement was observed by week two after a single dose and, for the majority of responding patients, was maintained through week 54. Physical function and quality of life (SF36) were similarly improved. Remicade also was shown to be particularly effective in treating axial (spinal and lumbosacral regions) symptoms of the disease. The safety profile of Remicade for treating AS is similar to its safety profile for its other approved indications. About Remicade Remicade is currently marketed in the EU for rheumatoid arthritis and Crohn's disease, and is a worldwide market leader among TNF-alpha therapies, with more than 400,000 patients treated. In RA, Remicade, in combination with methotrexate, is indicated for use for the reduction of signs and symptoms and the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. In this patient population, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in RA, CD and AS, and may also be important in a wide range of other immune-mediated inflammatory disorders. Schering-Plough markets Remicade in all countries outside of the United States, except in Japan and parts of the Far East where Remicade will be marketed by Tanabe Seiyaku, Ltd. Centocor, Inc. has exclusive marketing rights to the product in the United States. Important Information Regarding EU Labeling for Remicade Many people with heart failure should not take Remicade. Prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor immediately if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of the feet). There are reports of serious infections, including tuberculosis (TB) and sepsis, that have been associated with Remicade therapy. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB. If a patient has latent (inactive) TB, his or her doctor should begin TB treatment before starting Remicade. Patients who are prone to or have a history of infections, currently have one, or develop one while taking Remicade should tell their doctor immediately. Patients should also tell their doctor if they have or have had a disease that affects the nervous system, or if they experience any numbness, tingling or visual disturbances. There are also reports of serious infusion reactions including hives, difficulty breathing and low blood pressure. In clinical studies, some patients experienced the following common side effects: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion, such as rash or itchy skin. For complete Remicade EU labeling information, go to the link: http://www.eudra.org/humandocs/humans/epar/remicade/remicade.htm, on the EMEA web site. In the United States, complete U.S. prescribing information and other product information is available at http://www.remicade.com. SOURCE: Schering-Plough Corporation

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