Cimzia

UCB files for Cimzia RA approval in Europe

John Carroll — Tue, 01 Jul 2008 10:36:49 -0400

UCB is taking its case to make Cimzia the first PEGylated anti-TNF biologic available to rheumatoid arthritis patients in front of the European Medicines Agency. Recently approved for Crohn's, Cimzia is one of the most closely watched RA therapies in late-stage development. And UCB has gathered data on the responses of 2,300 patients in late-stage trials.

"Along with a fast onset of action, Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients' physical function," said Olav Hellebo, president of inflammation operations for UCB. "With millions of people suffering from rheumatoid arthritis across the globe, Cimzia, when approved, will provide a new and effective treatment option for this debilitating condition."

- read the UCB release

UCB CEO plots strategy following Cimzia approval

Thu, 24 Apr 2008 06:59:58 -0400

Fresh off the FDA's approval of Cimzia for Crohn's disease, UCB chief executive Roch Doliveux forecast a swift regulatory success in Europe. Cimzia is one of the most closely watched late-stage drugs for arthritis, and Doliveux was clearly buoyed by the 20 percent jump in the value of UCB shares following yesterday's regulatory win. UCB's pegylated anti-TNFa therapy offers a new, easier form of administration than existing arthritis therapies and analysts have been bullish about its market potential.

The CEO also forecast a resolution of its manufacturing problems with Neupro, which was recalled in the U.S. after formulation problems were revealed. Cimzia, Vimpat, Neupro and Rikelta are all expected to add to the company's performance, says Doliveux, after which UCB plans a "breakthrough" phase.

- see UCB release on the approval
- read the AFX report

EMEA shoots down UBC's Cimzia

Fri, 16 Nov 2007 06:59:55 -0500

It looks like UBC has struck out in the EU. The EMEA told the company that the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Cimzia, a treatment for Crohn's disease. The CHMP raised several issues that UBC plans to address in order to gain approval by mid-2008. The company said it will submit an appeal on the decision. UBC's shares plunged on the rejection. Back in March the FDA told UBC that it would need to conduct another trial of Cimzia, shocking investors and delaying the drug's U.S. approval by at least two years.

"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease," said Melanie Lee, Executive Vice President Research & Development of UCB.

- check out this release on the rejection

Related Articles:
FDA shocks UCB investors with Cimzia trial demand. Report
Late-stage Cimzia trial for RA hits endpoints. Report
UCB submits BLA for Cimzia. Report