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UCB Submits BLA for Crohn’s Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 clini...

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