Abbot Laboratories’ Humira may not be effective in ulcerative colitis patients who don’t respond to conventional therapies, according to US regulators.
Two trials studying Humira, a rheumatoid arthritis drug, when used for moderate to severe ulcerative colitis met the studies’ goals, but the Food and Drug Administration (FDA) has questioned the “clinical meaningfulness” of a difference between patients’ reactions to the drug and a placebo, reports Bloomberg Business Week.
The FDA also believes that limitations on the studies by Abbott “introduced uncertainty” to the results they announced. The staff stated:
“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.”
Humira was originally cleared for rheumatoid arthritis treatment in 2002, and the FDA will meet on August 28 to consider expanding the drug’s approval for ulcerative colitis as well, according to The Chicago Tribune. Abbott’s competitor Johnson & Johnson currently sells Remicade, a treatment for both rheumatoid arthritis and ulcerative colitis.
Unlike Remicade, Humira does not require a doctor to administer the medicine because it can be self-injected, according to John Medich, head of clinical development for immunology at Abbott Park.
The ulcerative colitis study by Abbott Laboratories showed that, of the 248 patients treated with Humira, 17 percent showed a clinical remission while 8.5 percent who took a placebo had remission after a year. While the FDA staff recognized the benefit of Humira’s convenience compared to Remicade, they also questioned 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.”