Remicade Approved to Treat Ulcerative Colitis in Children Older Than 6 Years

Janssen's Remicade has been approved by FDA to treat moderately to severely active ulcerative colitis in children older than 6 years who have had inadequate response to conventional therapy.

The U.S. FDA has approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

Remicade manufactured by Janssen Biotech Inc. reduces signs and symptoms of UC and induces and maintains clinical remission in these patients.

"With the approval of Remicade, children with moderately to severely  active  ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option," said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research. "However, there are serious risks associated wi