FDA panel gives Humira a thumbs-up for colitis

Abbott Laboratories' ($ABT) jewel in the crown is the anti-inflammatory drug Humira. It's not only the drugmaker's biggest seller, but it's also set to become the biggest-selling product in the world, now that blockbusters like Lipitor and Plavix have gone off patent. Last year, it brought in $8 billion.

Humira is also crucial to Abbott's split-up plans. Later this year, the company will hive off its pharma division, Humira and all, into a separate, publicly traded company known as AbbVie. The bigger Humira looks at the time, the better.

Fortunately, Abbott has been working for years to build up new uses for Humira, beyond its current indications in rheumatoid arthritis and Crohn's disease, among others. One of the biggies--ulcerative colitis--just cleared a big hurdle yesterday, when an FDA advisory panel voted 14-2 in favor. If Humira can nab that approval, then it will be on its way to $1 billion in additional sales expected from ulcerative colitis and other new indications, Bloomberg reports.

The advisory committee's vote was not without reservation, however. FDA reviewers had raised some questions about Humira's efficacy, particularly at lower doses. Some panelists agreed that Abbott hadn't sufficiently shown just which Humira doses work best in patients with moderate to severe ulcerative colitis. In the end, the committee backed FDA's conclusion that Abbott hasn't yet identified the proper dose for this particular ailment.

"There is a need and desire to explore higher doses, and understand the need and potential for this drug," NIH scientist Ivan Fuss said (as quoted by Bloomberg). "It's almost like a learner's permit for a driver's license. There's more experience needed."

But FDA pointed out--and the committee agreed--that Humira is more convenient for patients than other alternatives. Johnson & Johnson's ($JNJ) Remicade, for instance, has to be administered through an IV, while Humira can be self-injected.

The agency is set to decide on the new use by the end of September. That's likely to be before the big spinoff. FDA could give AbbVie a hand with an approval--or it could require more studies, as staff reviewers suggested. Or, it could simply nix the idea, as it did last November. Stay tuned.

- read the Bloomberg story

Special Report: Humira --Top 10 Drug Advertising Spends -- Q1 2012

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