UCB’s Cimzia fails to appeal to European regulators
pharmafile | April 1, 2008 | News story | Sales and Marketing |Â Â EUÂ
UCB's Crohn's disease drug Cimzia has been denied European approval for a second time after regulators said lacked sufficient evidence to back up its safety profile.
Cimzia first failed to gain approval for the treatment of severe, active Crohn's disease in November 2007.
It showed only marginal effectiveness – too low to be relevant for patients – and the study of its use as a maintenance treatment did not last long enough to give meaningful information about the medicine's long-term effects. There was also concern over a possible increased risk of bleeding in patients.
UCB appealed the decision and regulators, despite no longer being concerned about an increased risk of bleeding, were still not reassured by Cimzia's general safety profile, saying its benefits did not outweigh the risks.
The company is disappointed by the CHMP's negative opinion, but Olav Hellebo, Senior Vice President UCB & President Inflammation Operations, said: "Nevertheless, we are pleased that specific safety and quality concerns raised by the committee in November, were resolved through the appeal process."
UCB said it remains committed to the development of medicines to satisfy the needs of patients with autoimmune disorders, but has not made clear its next steps with regards to Cimzia.
The application for Cimzia in severe, active Crohn's disease was to have been the first of a number of possible indications for the drug, which was poised to enter the already competitive anti-TNF market.
The leading anti-TNF For Crohn's disease is currently Schering-Plough and Centocor's Remicade, which was joined on the market last year by Abbott's Humira.
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