FDA Approves New Drug for Crohn's Disease

The Associated Press Published: Oct 3, 2001

WASHINGTON (AP) - Sufferers of Crohn's disease won a new treatment Wednesday that promises to decrease the intestinal inflammation that causes much of the disorder's misery. The Food and Drug Administration approved Entocort EC, saying the capsule promises fewer side effects than other steroids, such as prednisone, that are used to treat Crohn's.

Entocort EC capsules are formulated to release the medication, known chemically as budesonide, once they reach the intestine. That means less of the steroidal drug is absorbed into the body than other Crohn's treatments allow, the FDA said.

Crohn's disease is a chronic bowel inflammation that eventually breaks down the intestinal wall. It afflicts more than 500,000 Americans, most of them under age 30. Symptoms include severe and persistent diarrhea, abdominal pain, fever, fatigue and weight loss. About half of all Crohn's patients at some point require surgery to remove intestinal obstructions or repair holes in the bowel.

The cause isn't known, although a recently discovered genetic abnormality renders some families particularly vulnerable. There is no known cure, although certain drugs can ease symptoms in some patients. The most common inflammation-reducing drugs are steroids, but long-term steroid use can cause some serious side effects.

In clinical trials of almost 1,000 patients with mild to moderate Crohn's, about half of patients taking Entocort EC experienced improvement in their symptoms after two months of therapy, said manufacturer AstraZeneca.

Entocort users experienced fewer of the typical side effects of Crohn's treatment, including facial swelling and acne, the FDA said. Typical Entocort side effects included headache, respiratory infection and nausea, the agency said.

AstraZeneca said the prescription medication would be in pharmacies later this year, and cost about $5.40 a day.

AP-ES-10-03-01 1843EDT

-- Anonymous, October 03, 2001