UCB Submits BLA for Crohn’s Drug

UCB has submitted a BLA to the FDA for the approval of Cimzia for the treatment of Crohn’s disease. If approved, Cimzia would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn’s disease.

The BLA includes safety and efficacy data from clinical trials in more than 1,500 patients with Crohn’s disease. The studies (PRECiSE 1 and PRECiSE 2) that support the BLA submission met their primary endpoints by demonstrating that Cimzia induced clinical response and maintained clinical response and remission in a significant percentage of patients with Crohn’s disease. The Cimzia BLA package represents the largest biologic clinical trial database and broadest, in terms of patient types, submitted to the FDA for Crohn’s disease treatment, according to UCB.