Results from two phase III trials, named ACT1 and ACT2, reveal that, among patients with moderate to severe active ulcerative colitis (UC) who experienced an inadequate response to conventional therapy, nearly 70% of patients at week eight demonstrated significant improvement in their symptoms with Remicade (infliximab) therapy.
Data from the trials show Remicade met primary and secondary endpoints of clinical response, clinical remission and mucosal healing.
Currently, there are no biologic therapies approved to treat moderate to severe UC, and with limited alternative treatment options, some patients face surgical removal of the colon, otherwise known as a colectomy.
An application for the approval of Remicade to treat moderate to severe UC was submitted in the US in March 2005. Based on these data from ACT 1 and ACT 2, Remicade may now be eligible for FDA priority review.