Schering-Plough Corporation announced that the European Commission has granted approval of Remicade (infliximab) in the European Union (EU) as first-line therapy for the treatment of early rheumatoid arthritis (RA).
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, 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," he added.
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.
Patients in the ASPIRE study had an average of only seven months of clinical disease duration yet more than 90 per cent 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.
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.
Importantly, in the subgroup of patients who had no joint damage at initiation of the study, 79.7 per cent of these patients treated with Remicade and methotrexate continued to show no joint damage at week 54, versus 63 percent with methotrexate alone.
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, the release says.