FDA Approves UCB's Cimzia for Crohn's Disease
Posted on: Wednesday, 23 April 2008, 06:00 CDT
UCB has announced that the FDA has approved Cimzia for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.
The approval of Cimzia was based on safety and efficacy data from clinical trials in more than 1500 patients with Crohn's disease. Each pivotal study demonstrated that a statistically significant greater proportion of moderate to severe Crohn's disease patients achieved and sustained clinical response with Cimzia for up to six months, compared to placebo. These data also showed that of the patients who were in remission after initial dosing, the majority maintained remission with no dose escalation.
Roch Doliveux, CEO of UCB Group, said: "Cimzia is a UCB biological innovation that will provide a monthly treatment option for patients suffering from Crohn's disease. Cimzia will be available to doctors and Crohn's patients in the US, which represents 70% of the world Crohn's anti-TNF market, within the next 48 hours."
Source: Datamonitor
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