Biotech Values

[DewDiligence]

FDA panel backs Humira for UC by 15-2 vote:

http://www.reuters.com/article/2012/08/28/us-fda-abbott-idUSBRE87R0ZT20120828

Abbott hopes to expand its use to people with moderate to severe ulcerative colitis, a chronic disease that causes ulcers in the colon and affects about 700,000 Americans. The drug would only be used in people who have not had success with other medicines for the condition.

If approved for ulcerative colitis, Humira would be the first biologic drug that people could inject themselves, Abbott said. Johnson & Johnson's Remicade, a competing treatment that works in a similar way to Humira, must be given intravenously in the hospital. [Enbrel, the other TNF-a drug, is not FDA-approved for UC.]

Abbott has said new uses for Humira could add more than $1 billion in sales, though it did not specify projections for ulcerative colitis. Humira was already approved for ulcerative colitis in the European Union [#msg-74255837], and Abbott is also testing it in other conditions such as pediatric Crohn's disease.