EMEA Rejects Cimzia, UCB Requests Agency Reexamine Application

UCB will appeal a decision by the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use recommending against approving the firm’s Cimzia for the treatment of moderate to severe Crohn’s disease.

The EMEA cited both efficacy and safety reasons for recommending against approving Cimzia (certolizumab pegol). However, UCB said the product is effective, and it hopes to get the committee to interpret the data differently. The application included data from an 18-month, open-label study and a six-month, double-blind, placebo-controlled trial. The drug was approved in Switzerland for the treatment of Crohn’s disease in September, UCB said.

The EMEA also was concerned about a possible association of increased bleeding with the product, but the company said bleeding rates were similar in both the active and placebo study arms. In addition, the agency said the firm would not be able to monitor the quality of the medicine to an acceptable manner. UCB said the committee’s concerns related to documentation of the production process, not the manufacturing process itself, and it is prepared to submit the necessary documents to the agency.

A decision on the firm’s appeal is expected in the first half of 2008.