UCB's Cimzia: FDA-Approved for Chron's Disease

Filed in archive FDA Approvals , Treatment on April 24, 2008

With no cure and still of unknown cause - Crohn's disease - is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide.

Chron's disease can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain.

Now, the US FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with moderate to severe Crohn's disease who have not responded to conventional therapies.

"Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research.

"This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

Cimzia is a product of UCB, Inc. (Smyrna, GA.).

Find more details from the FDA News.

[In Photo: The Crohn's Disease and Ulcerative Colitis Fact Book (Hardcover) from Amazon)