12:00 AM
Sep 03, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Humira adalimumab regulatory update

FDA's Gastrointestinal Drugs Advisory Committee voted 15-2 that the benefits of Abbott's Humira adalimumab outweigh the potential risks in patients with moderately to severely active ulcerative colitis. While panel members were disappointed by Humira's magnitude of benefit, they felt the mAb against tumor necrosis factor (TNF) alpha could benefit patients who don't respond to available therapies.

Humira met the primary endpoints in the 2 Phase III trials included in the sBLA. In 1 trial, 18.5% of Humira patients achieved remission at week 8 vs....

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