FDA Approves New Ulcerative Colitis Treatment for Children

Today, the US Food and Drug Administration approved a new drug known as Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy.

Remicade has been shown to reduce the signs and symptoms of UC while also inducing and maintaining clinical remission in these patients. UC is a form of inflammatory bowel disease (IBD) that affects 40% of all child IBD patients. The condition affects 50,000 to 100,000 children in the US.

Dr. Donna Griebel, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research, stated, “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.” Still, Griebel did warn, “there are serious risks associated with its use. Patients and their families should always discuss with their physicians the risks and benefits of using a medication before deciding to start treatment.”

Remicade carries a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi, or bacteria. Strange cases of cancerhave also been reported in adolescent and young adult patients using the agents, including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma.

The safety and efficacy of the tumor necrosis factor (TNF) blocker, Remicade, was supported by a multi-center, randomized, open-label study in 60 children ages 6 years to 17 years with moderate to severe UC. Each of the participants had previously failed to respond to or tolerate conventional treatment.

The FDA not only approved Remicade for UC, but also for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children 6 years and older. Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults have also been approved for treatment by the new TNF blocker.

The FDA stressed that children should have all of their vaccines brought up to date before starting treatment with Remicade and should not receive live vaccines while taking the agent.

Around the Web

FDA Approves Remicade to Treat Ulcerative Colitis in Children 6 Years and Older [US Food and Drug Administration]

Remicade Approved for Ulcerative Colitis in Children [US News & World Report]