FDA Grants REMICADE(reg) (Infliximab) Fast Track Designation for Active Ulcerative Colitis

Main Category: GastroIntestinal / Gastroenterology
Article Date: 17 Dec 2004 - 10:00 PDT

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Centocor, Inc, announced today that REMICADE(reg) has received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of active ulcerative colitis (UC), a chronic and debilitating disease of the colon, or large intestine, that affects nearly a half million people in the United States. The FDA's Fast Track regulations, based upon the FDA Modernization Act of 1997, are designed to assist in the development of products that may treat serious or life-threatening diseases and address an unmet medical need. Development programs receiving Fast Track Designations typically receive FDA Priority Review (six-month versus standard 10-month review). There are currently no FDA approved biologic therapies to treat moderately-to-severely active UC, which may cause patients to face a colectomy (surgical removal of the colon).

"There is currently a significant unmet need in the treatment of UC, especially when you consider that surgery is often the only option when conventional therapies fail," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "Once data are submitted to the FDA, a Fast Track Designation could be an important step in providing a much-needed treatment option for the 500,0000 Americans living with UC. We look forward to working closely with the FDA through the application review process."

The use of REMICADE(reg) for the treatment of UC is being investigated through two multicenter, Phase III randomized, double-blind, placebo-controlled, parallel-treatment clinical trials to evaluate the treatment's safety and efficacy in people with active UC. Top-line data from these trials are expected to be presented during the Digestive Disease Week meeting in Chicago in May 2005.

Centocor, Inc., is planning simultaneous submissions of REMICADE(reg) applications for the treatment of active UC in the United States and Europe. Centocor, Inc., discovered REMICADE(reg) and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.

About REMICADE(reg)

REMICADE(reg) is the global market leader among anti-tumor necrosis factor alpha (TNF-a) therapies and the only agent approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE(reg) is indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

In September, the European Commission gave approval for expanded labeling for REMICADE(reg), in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drugs.

REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE(reg) is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE(reg) patients may require as few as six treatments each year. The safety and efficacy of REMICADE(reg) have been well established in clinical trials over the past 12 years and through commercial experience with more than a half million patients treated worldwide.

About Ulcerative Colitis

Ulcerative colitis, a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S., is marked by the inflammation and ulceration of the colon mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain.. Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes bloody) and often severe abdominal pain, often leading to unwanted weight loss, blood loss and a host of secondary complications. Ulcerative colitis is a chronic disease, and there is no cure. Although progress has been made in IBD research, investigators do not know what causes this disease.

Important Information for Patients

Many people with heart failure should not take REMICADE(reg); so prior to treatment, you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB.

Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE(reg). REMICADE(reg) can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE(reg), tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE(reg). Nervous system disorders have also been reported.

Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling or visual disturbances while taking REMICADE(reg). Reports of lymphoma (a type of cancer) in patients on REMICADE(reg) and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer.

Serious infusion reactions have been reported with REMICADE(reg), including hives, difficulty breathing and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin.

About Centocor, Inc.

Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life.

Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products. Centocor, Inc., discovered REMICADE(reg) and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.