Remicade is indicated for the treatment of pediatric patients with moderately to severely active UC, who have had an inadequate response to conventional therapy earlier.
The committee’s decision is backed by the results of an open-label, randomized Phase 3 trial investigating the safety and efficacy of Remicade in patients suffering from moderately to severely active UC.
The benefit:risk profile supports the approval of Remicade for pediatric UC indications including induction and maintenance of clinical remission and induction of mucosal healing.
Centocor Research & Development division of Johnson & Johnson Pharmaceutical R&D Immunology Development head and vice president Jerome Boscia said they hope the FDA will consider this recommendation and approve Remicade for this orphan disease.