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news.Johnson & Johnson's Centocor unit has submitted a supplemental biologics license application seeking approval for Remicade for the inhibition of structural damage and improving physical function in patients with psoriatic arthritis.
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The filing is based on long-term data from two double-blind, placebo-controlled trials showing inhibition of structural damage and sustained improvement in functional status.
Psoriatic arthritis is a chronic, progressive and potentially debilitating disease that causes joint inflammation and is frequently associated with skin plaques of psoriasis.
In May 2005, Remicade was approved in the US for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis and back in September of 2004, it received European Union (EU) approval, in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease- modifying anti-rheumatic drugs (DMARDs).
“Findings from (the trial) IMPACT 2 show that early intervention with Remicade therapy can significantly inhibit the progression of joint damage, which is an important factor in the long-term prognosis of patients with psoriatic arthritis,” said Dr Jerome Boscia, senior vice president of clinical R&D at Centocor.