Going into its Food and Drug Administration advisory committee meeting yesterday, Abbott Labs
The advisory committee, on the other hand, was pretty happy with the data package. The panel voted 15-to-2 recommending that the FDA approve the drug. That's not exactly unanimous, but it should be good enough to influence the FDA's decision.
Whether the vote can influence the agency enough is the big question. The advisory committee's vote is just that: advisory. The FDA has the final say. It already rejected Humira's use in ulcerative colitis back in November.
The drug passed its clinical trial, putting more patients into remission than placebo, but the FDA was worried that the margin of victory wasn't sufficient to justify the potential side effects. Because it tempers the immune system, patients taking Humira have an increased risk of infection.
If there wasn't another treatment for ulcerative colitis, Humira might have an easier path to approval, but Johnson & Johnson
Unfortunately, the FDA cares a lot more about efficacy and safety than it does about convenience. If the FDA got the feeling that the doctors on the panel were basing their vote mainly on the convenience factor, the agency is likely to stick to its previous decision and turn down Humira again.
If Humira is approved for ulcerative colitis, it may have just a few years of being the most convenient drug on the market. Pfizer's
As binary events go, this one seems like a crapshoot. I could see it going either way; it might come down to which side of the bed the FDA reviewers wake up on when the final decision is handed down.
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