Health Canada approves Simponi (golimumab) for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Centocor Ortho Biotech Inc. and Schering-Plough Corporation has announced that Health Canada has granted approval of Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

With this approval in Canada, Simponi, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms in adult patients with moderately to severely active RA; reducing signs and symptoms in adult patients with moderately to severely active PsA, alone or in combination with MTX; and reducing signs and symptoms in adult patients with active AS who have had an inadequate response to conventional therapies. Simponi is the first biologic therapy to be approved concurrently in three distinct rheumatologic diseases. Schering-Plough anticipates that the medication will become available in Canada in the second half of 2009.

"This first approval marks a major milestone in the clinical development program for Simponi," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. "More importantly, the approval of Simponi expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly."

"This is the first approval for Simponi, one of the five stars in our late-stage pipeline," said Thomas P. Koestler, Ph.D., executive vice president, Schering-Plough Corporation and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands our leading immunology franchise in meeting the needs of the rheumatology community."

Centocor Ortho Biotech Inc. developed and discovered Simponi 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, Indonesia and Taiwan, where Simponi will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where Simponi will be exclusively marketed by Janssen-Cilag; and China, where Simponi will be exclusively marketed by Xian-Janssen.

In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with RA, PsA and AS.

In June 2008, Centocor Ortho Biotech Inc. announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with active forms of RA, PsA and AS.

The approval of Simponi in Canada is based on data from five pivotal clinical trials: GO-BEFORE, GO-FORWARD, GO-AFTER, GO-REVEAL and GO-RAISE. Each trial found Simponi to be effective in reducing the signs and symptoms of RA, PsA and AS.

Rheumatoid Arthritis

RA is a chronic and debilitating disease that affects approximately 4 million people in Canada. 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. 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 30 and 50, in the peak of their productive years.

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. It typically begins in the late teens and early twenties, 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, ankylosing spondylitis is a systemic inflammatory disease that, in addition to its effect on the spine, can affect internal organs, peripheral joints and vision.

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. The first once-monthly subcutaneous anti-TNF-alpha therapy, Simponi is approved in Canada for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, and is available either through the Simponi SmartJect auto injector or a prefilled syringe. Simponi is also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis.

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