J&J unit Janssen-Cilag withdraws MAA for Comfyde based on negative CHMP feedback

Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johns, has withdrawn its application to the European Medicines Agency (EMEA) for a centralized marketing authorization for its epilepsy drug candidate Comfyde (carisbamate) 100mg, 200mg, 400mg and 600mg film-coated tablets.

This drug was intended to be used for adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 years or older. The application for Comfyde was submitted to the Agency on August 27, 2009. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter to the EMEA, the company stated that its decision to withdraw the application was based on the feedback from the CHMP indicating that the Committee is unlikely to reach a favourable opinion without additional efficacy data, which at this time cannot be provided. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.