Health Boards
Thu-22-09-2011, 14:18 PM
Janssen Inc. announced today that Health Canada has expanded the approved indication for SIMPONI® (golimumab), in combination with methotrexate, to include the inhibition of progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who had not previously been treated with methotrexate. Health Canada also approved an expanded indication in the improvement of physical function in adult patients with moderately to severely active rheumatoid arthritis.1 Rheumatoid arthritis is an inflammatory condition that if left untreated, can lead to permanent damage such as joint deformity and disability.2
"This is an exciting and welcome development for Canadians with moderate to severe rheumatoid arthritis," said Dr. Edward Keystone, Professor, Faculty of Medicine, University of Toronto and one of the principal investigators of the studies on which the approval was based. "Inhibiting the progression of the disease and improving physical function, allowing patients to retain their ability to carry out daily tasks, are key considerations in managing this potentially debilitating autoimmune condition."
The new approval is based on data from the Phase 3 GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) trial that showed the efficacy of SIMPONI®, in a methotrexate-naïve patient population, in reducing the rate of joint damage as evaluated by X-ray; and on data from the Phase 3 GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) trial that showed sustained improvement, in physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI).3,4,5
A chronic inflammatory condition and autoimmune disease, rheumatoid arthritis affects approximately 300,000 Canadians, with three times as many women as men having the disease.2 It most often develops in young adulthood (ages 25 to 50) and is characterized by symptoms of joint inflammation, stiffness and pain that over time involves more joints on both sides of the body.2 SIMPONI® was first approved in Canada in 2009 for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI® is a 50 mg once-monthly, subcutaneously-administered anti-tumor necrosis factor (TNF)-alpha treatment.1
"This is an exciting and welcome development for Canadians with moderate to severe rheumatoid arthritis," said Dr. Edward Keystone, Professor, Faculty of Medicine, University of Toronto and one of the principal investigators of the studies on which the approval was based. "Inhibiting the progression of the disease and improving physical function, allowing patients to retain their ability to carry out daily tasks, are key considerations in managing this potentially debilitating autoimmune condition."
The new approval is based on data from the Phase 3 GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) trial that showed the efficacy of SIMPONI®, in a methotrexate-naïve patient population, in reducing the rate of joint damage as evaluated by X-ray; and on data from the Phase 3 GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) trial that showed sustained improvement, in physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI).3,4,5
A chronic inflammatory condition and autoimmune disease, rheumatoid arthritis affects approximately 300,000 Canadians, with three times as many women as men having the disease.2 It most often develops in young adulthood (ages 25 to 50) and is characterized by symptoms of joint inflammation, stiffness and pain that over time involves more joints on both sides of the body.2 SIMPONI® was first approved in Canada in 2009 for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI® is a 50 mg once-monthly, subcutaneously-administered anti-tumor necrosis factor (TNF)-alpha treatment.1
