Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of SIMPONI(TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).
Upon Commission approval in the European Union, SIMPONI given as a 50 mg subcutaneous injection once a month will be indicated for:
- In combination with methotrexate, the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
- Alone or in combination with methotrexate, the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
- The treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.
"With today's decision, SIMPONI moves one step closer to becoming the first once-monthly subcutaneous anti-TNF therapy for the treatment of rheumatoid arthritis,psoriatic arthritis and ankylosing spondylitis in the European Union," said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc. "We are optimistic that SIMPONI will be a welcome addition as a new anti-TNF treatment option for rheumatologists, and adults living with these inflammatory conditions who are seeking an effective and convenient therapy."
Upon receipt of the corresponding Commission Decision, SIMPONI will be the first and only once-monthly subcutaneous anti-tumor necrosis factor (TNF) alpha therapy approved in Europe
for the simultaneous treatment of RA, PsA, and AS. SIMPONI will be available in two device forms, either through the SmartJect(TM), a novel autoinjector designed to meet the needs of arthritis patients, or as a prefilled syringe.
The CHMP recommendation serves as the basis for a European Commission approval decision. A Commission approval of this application will result in Marketing Authorization with unified labeling that will be valid in all European Union Member States.
In April 2009, SIMPONI(TM) (golimumab) was approved by the U.S. Food and Drug Administration (FDA) and Health Canada for the treatment of moderately to severely active RA, active PsA and active AS.
"This positive opinion is an important step toward an approval as SIMPONI has the potential to benefit a broad range of patients in Europe by offering once-monthly subcutaneous treatment administered through an autoinjector device designed specifically with arthritis patients in mind," said Thomas P. Koestler
, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Schering-Plough continues to pride itself on being a leading provider of rheumatic disease therapies within the European rheumatology community." The efficacy and safety of SIMPONI have been studied in a comprehensive Phase 3 development program that included more than 2,000 patients living with moderately to severely active RA, active PsA and active AS. In Phase 3 rheumatoid arthritis trials, SIMPONI was shown to be effective regardless of prior treatment experience, which included patients inadequately responding to methotrexate and patients previously treated with anti-TNF agents.
Centocor Ortho Biotech Inc. developed and discovered golimumab and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesiaand Taiwan, where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China, where golimumab will be exclusively marketed by Xian-Janssen.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic and debilitating disease that affects more than three million people in Europe. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, over time it can cause permanent joint deformity and severe disability. RA can occur at any age, but is most common in adults 30-50 years old and is two-to-three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation over time. The Arthritis Research Campaign estimates one in 50 people have psoriasis. Of these, about one in 14 will develop PsA. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages of 30 and 50, in the peak of their productive years.
About Ankylosing Spondylitis
Ankylosing spondylitis is a painful and progressive form of spinal arthritis, and symptoms of inflammatory back pain often first present in people under the age of 35 years. On the European continent, it is estimated that prevalence ranges from 0.2 to one percent of the entire population. It typically begins in the late teens and early 20s, and in severe cases can result in fusing of the spinal vertebrae and cause structural damage to hips and other joints. Often misdiagnosed as "just back pain" or undifferentiated arthritis, AS is a systemic inflammatory disease that, in addition to its effect on the spine, can affect internal organs, peripheral joints and vision.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Upon approval in the European Union, SIMPONI will be the first once-monthly subcutaneous anti-TNF-alpha therapy for the treatment of moderate-to-severe, active RA, active and progressive PsA and severe, active AS, and will be available either through the SIMPONI SmartJect(TM) auto injector or a prefilled syringe. The approved dose for SIMPONI in the US and Canada is a 50 mg subcutaneous injection given once a month.
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