FDA Approves First Medication Specifically for Crohn’s Disease

The government approved the first drug specifically for Crohn’s disease, a painful inflammation of the digestive system that affects about 1 million Americans.

The Food and Drug Administration announced Monday that it was licensing infliximab as the first medication for Crohn’s. The drug also is being tested for treatment of rheumatoid arthritis, a bone deterioration disease.

Part of a new class of drugs, infliximab blocks the action of a natural protein that can promote inflammation. The drug was made using both human and mouse antibody genes.

“This is clearly a breakthrough drug in the treatment of Crohn’s,” said Dr. Stephen B. Hanauer, a professor of medicine and a specialist in digestive disorders at the University of Chicago Medical Center. “This is not a cure. We still don’t know what causes Crohn’s.”

Crohn’s can cause patients to “suffer terribly,” said Hanauer. In severe cases, there can be persistent diarrhea, pain, bleeding, fever and weight loss. In some patients, the disease drills a hole from the gut through to the skin.