Remicade(r)Approved in European Union for Treatment of Early Rheumatoid Arthritis
REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms, as well as the improvement in physical function in patients with severe, active and progressive disease not previously treated with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDS).
The approval follows a positive opinion granted in April by the EU's Committee for Proprietary Medicinal Products (CPMP), newly renamed the Committee for Medicinal Products for Human Use (CHMP), for the European Agency for the Evaluation of Medicinal Products (EMEA).
"This approval is an important milestone for patients with rheumatoid arthritis, as early intervention with REMICADE has now proven to be valuable in halting the progression of this debilitating disease," said Robert Spiegel, MD, chief medical officer and senior vice president, Schering-Plough.
"Early treatment with REMICADE has demonstrated safety and efficacy in preventing further damage to the joints of patients with rheumatoid arthritis and, in patients with established bone damage, can improve bone erosion scores, suggesting that repair may be possible."
The EU approval for REMICADE as a treatment for early RA is based on data from the ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) trial, a 54-week, randomized, double blind, active control study involving 1,049 patients with early RA (< 3 years duration) enrolled in 125 centers in North America and Europe.
ASPIRE is the first and only trial in early RA to demonstrate the superiority of REMICADE with methotrexate versus methotrexate alone in preventing progression of joint destruction and reducing disability as well as increasing clinical improvement. In these patients, a significant reduction in the rate of the progression of joint damage has been demonstrated.
Patients in the ASPIRE study had an average of only seven months of clinical disease duration yet more than 90 percent already had evidence of erosive joint changes. At week 54, results of the ASPIRE trial met all of the primary endpoints: demonstration of superior efficacy versus methotrexate alone in improvement of signs and symptoms of RA, prevention of progression of structural damage and improvement in physical function. Importantly, in the subgroup of patients who had no joint damage at initiation of the study, 79.7 percent of these patients treated with REMICADE and methotrexate continued to show no joint damage at week 54, versus 63 percent with methotrexate alone.
About Early RA
RA is a chronic, progressive disease and recent research demonstrates that a critical therapeutic window exists within the first years of disease onset when the progressive joint damage of the disease as measured radiographically can be "reset."(1),(2),(3) Joint damage can occur within two years of disease onset in 50-70 percent of RA patients.(4)
The American College of Rheumatology (ACR) suggests control of disease progression should start as early as possible to limit joint damage in RA.(3) RA is associated with substantial disability and economic losses, and one study showed that one- third of patients in the UK who were employed became work-disabled within two years of disease onset.(5)
About REMICADE
REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in rheumatoid arthritis (RA), Crohn's Disease (CD), ankylosing spondylitis (AS) and psoriasis, and may also be important in a wide range of other immune- mediated inflammatory disorders. REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly under supervision and monitoring of specialized physicians. In RA and CD patients, REMICADE is administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. The safety and efficacy of REMICADE have been well established in clinical trials conducted over the past 10 years and through commercial experience with more than 500,000 patients treated worldwide.
In the European Union, REMICADE is the only biologic indicated for the treatment of RA, CD, a serious gastrointestinal disorder, and AS, a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine.
For RA patients, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as 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.
In CD patients, REMICADE is indicated for the treatment of severe, active Crohn's disease in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant or who are intolerant to or have medical contraindications for such therapies. REMICADE is also indicated for the treatment of fistulizing, active Crohn's disease in patients who have not responded despite a full and adequate course of therapy with conventional treatment including antibiotics, drainage and immunosuppressive therapy.
REMICADE is also indicated for the treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States.
Important Information Regarding Labeling for REMICADE
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 feet). There are reports of serious infections associated with REMICADE therapy, including tuberculosis (TB) and sepsis. 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. If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE, he or she should tell his or her 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 with hives, difficulty breathing and low blood pressure. In clinical studies, some people 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 prescribing information, call Schering-Plough Corporation at +1 908-298-7616.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the market potential for REMICADE under expanded labeling. The extent that REMICADE will be prescribed will be determined by market forces. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume any obligation to update any forward-looking statement. There are no guarantees about the market performance of REMICADE under expanded labeling, Schering-Plough stock, or Schering-Plough's business. Actual results may vary materially from forward- looking statements due to many factors, including the extent of market acceptance of new indications for products; current and future branded, generic or over-the-counter competition; federal and state regulations and legislation; manufacturing issues; product availability; trade buying patterns; the outcome of litigation and investigations; and patent positions. For further details about these factors and other risks and uncertainties that may impact Schering-Plough's forward-looking statements, see the company's past and future Securities and Exchange Commission filings, including the company's first quarter 2004 10-Q.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world.
References:
(1) Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
(2) Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early 2nd line therapy: 5 year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
(3) American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
(4) van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol.
1995;34(suppl 2):74-78.
(5) Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology.
2000;39:1403-1409.
SOURCE Schering-Plough Corporation
06/21/2004
CONTACT: Media - Denise K. Foy, +1-908-298-7616, Investors - Janet Barth, +1-908-298-7436, or Lisa W. DeBerardine, +1-908-298-7436, or Alex Kelly, +1-908-298-7436, all of Schering-Plough Corporation
Web site: http://www.schering-plough.com
View drug information on Remicade.
Remicade (r) a aprobat în Uniunea Europeanã, pentru Tratamentul precoce Poliartrita reumatoidã - Remicade(r)Approved in European Union for Treatment of Early Rheumatoid Arthritis - articole medicale engleza - startsanatate