Humira adalimumab regulatory update

FDA approved an sBLA from AbbVie for Humira adalimumab to treat moderately to severely active Crohn's disease (CD) in pediatric patients ages ≥6 years who have had an inadequate response to corticosteroids or immunomodulators, such as azathioprine, 6-mercaptopurine or methotrexate. The human mAb against tumor necrosis factor (TNF) alpha is already approved for CD in adults. Humira has Orphan Drug status in the U.S. for pediatric CD.

Humira is approved in the U.S. and EU to treat adults with moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis and ulcerative colitis (UC) and to treat polyarticular juvenile idiopathic arthritis in patients ages ≥4 years. The drug is also approved in the EU to treat moderately to severely active CD in patients ages ≥6 years. ...