(By Balachander) Abbott Laboratories' (NYSE:ABT) best-selling rheumatoid arthritis drug, Humira, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe ulcerative colitis in adults.
The U.S. health regulator on Friday expanded the approved use of Humira (adalimumab) to include treatment of ulcerative colitis, which is a chronic disease that causes ulcers in the colon and affects about 620,000 Americans.
Humira, with estimates sales of $9 billion in 2012, is already approved to treat six conditions, including rheumatoid arthritis, psoriatic arthritis and Crohn's disease.
The FDA said the approval of Humira to treat ulcerative colitis provides an important new treatment option for patients who have had an inadequate response to conventional therapy.
According to the FDA, results from two clinical studies showed 16.5 percent to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 percent to 9.3 percent of patients receiving placebo.
The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug should only continue to be used in patients who have shown evidence of clinical remission by eight weeks of therapy, the agency said.
The FDA said common side effects of Humira include infections, reactions at the injection site, headache, and rash.
ABT shares dropped 1.08 percent to trade at $68.57 on Friday. The stock has been trading in the 52-week range of $48.96 to $70.41.