Humira For Ulcerative Colitis Seems Headed Towards Approval, Many Post-market Studies
• By Martin Berman-Gorvine
Unmet medical need for ulcerative colitis patients who have failed conventional therapy was enough to carry the day for Abbott’s drug at FDA’s Gastrointestinal Drugs Advisory Committee, but the optimal patient population and dose have not been established.
Abbott Laboratories Inc. will have a lot of work to do if and when FDA approves its tumor necrosis factor blocker Humira (adalimumab) for patients with moderately to severely active ulcerative colitis who have failed conventional therapy, an FDA advisory panel said.
