The FDA has approved infliximab to treat moderately to severely active ulcerative colitis in children 6 years and older who have not responded to conventional therapy.
Infliximab (Remicade, Janssen Biotech) reduces signs and symptoms of ulcerative colitis (UC) and induces and maintains clinical remission.
The safety and efficacy of infliximab were shown in a multicenter, randomized, open-label study of 60 children between the ages of 6 years and 17 years who had moderately to severely active UC. All subjects had failed to respond to or tolerate conventional treatment, according to a news release from the FDA.
“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,” Donna Griebel, MD, director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “However, there are serious risks associated with its use.”
Risks include serious infections and cancer, according to the release.
In addition to being approved for UC, infliximab is approved for the treatment of Crohn’s disease in adults and children 6 years and older, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis in adults.