Crohn’s Disease Antibody Backed
WASHINGTON (AP) _ Injections of a bioengineered antibody for treating certain difficult cases of the painful bowel disorder Crohn’s disease should be approved by the Food and Drug administration, government advisers decided Thursday.
The part-human, part-mouse antibody is called cA2 and is manufactured by Centocor Inc. The antibody, to be sold under the name Avakine, targets a human protein called tumor necrosis factor, blocking its ability to cause inflammation.
About 400,000 Americans have Crohn’s disease, a severe inflammation of the digestive tract that can strike repeatedly for years. Symptoms include diarrhea, pain, fever and weight loss. Most patients are treated with steroids; some require surgery to remove damaged parts of the intestine.
In one study of Avakine, 65 percent of the patients who received it showed significant improvement, including 33 percent who went into remission within four weeks of treatment, compared with 17 percent who received a dummy injection.
But the benefits quickly began wearing off. Centocor is studying whether Avakine could be a chronic therapy, but has no data yet.
The FDA advisers recommended Thursday that for now, Avakine be approved as a one-time option for moderate to severe patients who have failed standard drugs.
The panel urged Centocor to study its long-term effects, including the safety of repeat doses because of the potential possibility that suppressing tumor necrosis factor could eventually risk cancer or other side effects.
The FDA is not bound by its advisers’ recommendations but typically follows them.