UCB ‘disappointed’ by negative CHMP opinion on Cimzia

UCB has expressed its disappointment after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency upheld its decision to refuse the marketing authorisation application for Cimiza (certolizumab pegol).

The company had applied for marketing authorisation for the compound as a treatment for patients with Crohn’s disease and had previously appealed the decision adopted by the CHMP in November 2007.

This decision applies only to the filing for the compound for Crohn’s disease in the EU, UCB confirms.

Cimzia is a pegylated anti-tumour necrosis factor (TNF) and has a high affinity for human TNF-alpha.

Olav Hellebo, senior vice-president of the company and president of inflammation operations, said: “The CHMP’s negative opinion is disappointing for UCB.

“Nevertheless, we are pleased that specific safety and quality concerns raised by the committee in November, were resolved through the appeal process.”

He added that UCB remains dedicated to the development of drugs to satisfy the needs of individuals suffering from autoimmune conditions.

When the company first stated plans to appeal the decision of the CHMP last November, it added that it remains confident in the tolerability and efficacy of the drug.