Johnson & Johnson has withdrawn a European filing for its investigational epilepsy drug.
The European Medicines Agency says it has been notified by J&J’s Janssen-Cilag International unit the company’s decision to pull its application for a centralised marketing authorisation for the medicine Comfyde (carisbamate). The firm hoped the drug would be used for adjunctive treatment of partial onset seizures with or without secondary generalisation in patients aged 16 or older.
Janssen-Cilag says that the decision to withdraw the application was based on the feedback from the EMEA’S Agency’s Committee for Medicinal Products for Human Use. The latter had said that it was unlikely to reach a favourable opinion “without additional efficacy data, which at this time cannot be provided”.
The application was submitted to the agency in August and more information about Comfyde and “the state of the scientific assessment at the time of withdrawal” will be published on the EMEA’s website in the next few days.
The chances of Comfyde getting a thumbs-up in the USA are not looking too good either. Last August the US Food and Drug Administration sent a complete response letter to J&J’s Ortho-McNeil-Janssen Pharmaceuticals division. No details were given as to what further information the agency required.
