Remicade infliximab regulatory update

EMA's CHMP issued a positive opinion to expand the label of Remicade infliximab from Johnson & Johnson to include ulcerative colitis (UC) in patients ages 6-17 years who have an inadequate response to standard of care therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant or contraindicated to such therapies. The chimeric mAb against tumor necrosis factor (TNF) alpha is already approved in the EU for the indication in adults as well as to treat rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease in pediatric and adult patients, psoriatic arthritis and plaque psoriasis. ...