HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.
J&J subsidiary Janssen Biotech, which formerly went under the name Centocor Ortho Biotech, said the FDA’s Gastrointestinal Drugs Advisory Committee recommended approval of Remicade (infliximab) for moderately to severely active ulcerative colitis in children who have not responded to conventional therapies. The FDA granted orphan drug designation to Remicade as a treatment for UC in children in 2003; the agency gives orphan drug designation to drugs for diseases that affect fewer than 200,000 people.
“We are pleased with the advisory committee’s support for the approval of Remicade as a treatment for pediatric ulcerative colitis,” said Jerome Boscia, VP and head of immunology development for the Centocor Research & Development division of J&J Pharmaceutical Research & Development. “We hope the FDA will consider this recommendation and approve Remicade for this orphan disease.”