Abbott Laboratories (ABT)’ rheumatoid arthritis drug Humira, the company’s top-selling product, may not be effective in treating ulcerative colitis in patients who don’t respond to conventional therapies, U.S. regulators said.
While two trials on Humira’s use for moderate to severe ulcerative colitis met the studies’ goals, Food and Drug Administration staff in a report today questioned the “clinical meaningfulness” of a difference between patients’ reaction to the drug and a placebo. The staff also said limitations to the studies “introduced uncertainty” to the results.
“We question if there is sufficient evidence to suggest that Humira would offer any clinical advantage in any particular sub-population” for the inflammatory bowel disease, the staff said.
Agency advisers may take the staff report into account when they meet Aug. 28 to consider expanding approval of Humira, cleared in 2002 as a treatment for rheumatoid arthritis. The medicine generated $8 billion in sales last year for Abbott and competes with Johnson & Johnson (JNJ)’s Remicade, which is cleared to treat rheumatoid arthritis and ulcerative colitis. Pfizer Inc. (PFE) is studying its experimental rheumatoid arthritis pill tofacitinib in the bowel disease as well.
Unlike Remicade, which requires a doctor to administer the medicine intravenously, Humira can be self-injected, John Medich, head of clinical development for immunology at Abbott Park, Illinois-based Abbott, said in a telephone interview.
The risks with Humira are similar to those of Remicade, which are both TNF-antagonists and carry a boxed warning for serious infections such as tuberculosis and for malignancies.
Ulcerative colitis causes inflammation and ulceration in the lining of the colon or large intestine and affects 700,000 people in the U.S., according to Abbott. Conventional medications include corticosteroids and immunosuppressants.
Of the 248 ulcerative colitis patients treated with Humira in an Abbott study, 17 percent achieved clinical remission compared with 8.5 percent who took a placebo after a year, the company said in a May 2011 statement. Clinical remission is measured on a scale that evaluates stool frequency, rectal bleeding and ulcers sighted during endoscopy.
FDA staff acknowledged the benefit of convenience with Humira over Remicade, while questioning whether “moving patients from an effective treatment to potentially less effective treatment, while still exposing them to the comparable serious safety risks, is a concern.”
Abbott expects the FDA to make a decision on wider use of Humira by the end of the year, Medich said.
FDA listed additional data that may increase confidence in Humira to treat ulcerative colitis, including exploration of a higher dose and demonstration of benefit to a subgroup of patients.
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