On Friday (09-28-12) the FDA announced Adalimumab CAS# 331731-18-1 has been approved to treat moderate to severe ulcerative colitis, for those who are unresponsive to corticosteroids or immunosuppressants.
News of the approval comes as the FDA cites the two clinical trials with positive outcomes, involving 908 ulcerative colitis patients.
“Results from both studies showed 16.5% to 18.5% of patients treated with Humira achieved clinical remission compared with 9.2% to 9.3% of patients receiving placebo,” according to the FDA’s announcement.
“Additionally, in the second study, 8.5% of patients treated with Humira sustained clinical remission compared with 4.1% of patients treated with placebo.”
This is the seventh indication approved for adalimumab.
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