Abbott Laboratories looks likely to get another green light for Humira after advisors to the US Food and Drug Administration backed the blockbuster as a treatment for ulcerative colitis.
The agency's Gastrointestinal Drugs Advisory Committee has voted 15-2 that the benefits of Humira (adalimumab) outweigh its potential risks in treating patients with moderate-to-severe UC who have had an inadequate response to conventional therapy. The panel also voted 15-1 that the difference between the drug and placebo shown in two clinical trials were clinically meaningful.
The latter vote comes as a relief for Abbott, given that documents released last Friday by FDA staff suggested that more trials may be necessary. Last November, the agency rejected Abbott's first application to bag a UC approval and the staffers said the resubmitted data was of "questionable value".
However the advisory panel did vote 14-3 that the optimal Humira dose for UC has not been adequately established and called for post-approval studies. A final decision by the FDA is expected by the end of the year.
Humira, which had second-quarter revenues of $2.33 billion (+16.5%) is already approved for six conditions in the USA, including rheumatoid arthritis, psoriasis and Crohn's disease. It was given the green light for UC in Europe in April.
If approved for UC, Humira will go up against another biologic blockbuster, Johnson & Johnson's Remicade (infliximab), but one advantage of the Abbott drug is that patients can inject themselves; Remicade is given intravenously in hospitals