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Going into its Food and Drug Administration advisory committee meeting yesterday, Abbott Labs (NYSE: ABT ) needed a big win. The agency posted briefing documents for the panel of outside experts on Friday, and it was clear the agency isn't impressed with using Humira to treat ulcerative colitis, a type of inflammatory bowel disease.
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 (NYSE: JNJ ) and Merck's (NYSE: MRK ) Remicade is already approved for the indication. Humira is more convenient because it can be self-injected, while Remicade has to be infused in a medical office.
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 (NYSE: PFE ) oral anti-inflammatory tofacitinib looked good in an early trial testing it in ulcerative colitis; phase 3 trials are expected to end in 2015.
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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