REMICADE Receives Approval in European Union for Treatment of Moderate to Severe Plaque Psoriasis
The approval of REMICADE for the treatment of psoriasis is primarily based on data from the SPIRIT (Study of Psoriasis with Infliximab [REMICADE] Induction Therapy) and EXPRESS (European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study) trials. SPIRIT and EXPRESS were large multicenter, randomized, double-blind, placebo-controlled studies that assessed the efficacy of REMICADE in patients with plaque psoriasis with a Body Surface Area (BSA) of greater than or equal to 10 percent and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12. The primary efficacy endpoint in both studies was at least 75 percent improvement in PASI from baseline at week 10. "Today's approval underscores our commitment to provide a highly effective therapy for people living with psoriasis, a chronic and often debilitating condition," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "This approval reinforces the broad clinical utility of REMICADE, which is now indicated in the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis and has been used to treat more than 600,000 patients worldwide."
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