Humira nets new $500M-plus indication in U.S.

Abbott Laboratories' ($ABT) Humira is all set to become the biggest-selling drug in the world. Its sales have been taking trampoline leaps forward, boosting Abbott's pharma sales at a time when the company needs it most; the big pharma-unit spinoff is coming up in January.

Look for even bigger leaps ahead. Friday, the FDA approved the anti-inflammatory drug for its 7th indication: Ulcerative colitis, a chronic disease that affects some 620,000 patients in the U.S. The approval comes a bit later than Abbott wanted; the agency backed off approval late last year. But an FDA advisory panel finally backed the new use in late August.

Morningstar analyst Damien Conover told Reuters that he expects the colitis indication to add $500 million to Humira sales. Some analysts have said the boost could be even bigger. Back when folks thought Humira would have the new indication early this year, analysts predicted $9 billion in 2012 Humira sales, up from nearly $8 billion in 2011, PM Live reported at the time.

But the new indication has some built-in limitations. It applies only to patients who've never been treated with another TNF inhibitor, or who've failed on another TNF drug; and to patients whose steroid treatment has failed. The study data supporting Humira's use in ulcerative colitis showed up to 18.5% of those patients achieved clinical remission on Humira, compared with up to 9.3% of placebo patients.

- get the FDA release
- see the story from Reuters