Drug Gets FDA Panel Approval For Treatment Of Ulcerative Colitis
Lee Rannals for redOrbit.com — Your Universe Online
An FDA panel voted 15 to 2 that the benefits of Humira outweighed the risks it causes when treating the condition.
Humira is already approved to be used for six other conditions, and is most popular for its use to help in rheumatoid arthritis and Crohn’s disease patients.
The FDA panel is made of up of outside advisers to the agency, and the agency itself doesn’t have to follow the panel’s suggestions. However, it normally does, and a final decision on Humira is expected to be made by the end of the year.
The drug is one of the world’s top-selling drugs, and is projected to bring in $9 billion in sales this year.
Drug maker Abbott Laboratories is wanting to expand the use of Humira to ulcerative colitis, which is a chronic disease that can cause ulcers in the colon. The drug would be a last resort drug after patients have already tried using other medicines.
“There is a need and desire to explore higher doses, and understand the need and potential for this drug,” Ivan Fuss, a scientist with the National Institutes of Health in Bethesda, Maryland, told Bloomberg. “It´s almost like a learner´s permit for a driver´s license. There´s more experience needed.”
If Humira gets final approval by the FDA, it will become the first biologic drug that people could inject themselves with, to alleviate symptoms from ulcerative colitis.
The agency rejected an original proposal by Abbott for Humira to be used to treat ulcerative colitis patients, saying the clinical trials then were not conclusive enough.
Advisers also questioned whether Humira was even beneficial enough for patients in study trials, compared to those who had taken a placebo.
Abbott said opening up the drug for patients who suffer from this condition could help garner another $1 billion in sales.
About 700,000 people in the U.S. are currently suffering from ulcerative colitis, which causes symptoms like frequent diarrhea, abdominal pain, and rectal bleeding. In severe ulcerative colitis cases, there could be painful ulcers in the lining of the colon, which may bleed and produce pus and mucus.
Although Humira only showed it was able to produce slightly better results than a placebo, some believe even the slightest results make the drug useful for fighting the painful condition.
Humira is also approved for psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and juvenile idiopathic arthritis. It is used for pain relief, and as an anti-inflammatory in autoimmune diseases.
The Gastrointestinal Drugs Advisory Committee suggests Abbott carry out post-marketing studies if the drug gets the final approval by the FDA later this year.