Japan's Eisai Co. Ltd. said the new drug application for its epilepsy drug Fycompa has been accepted for review in China.
The National Drug Administration of China will review Fycompa as an adjunctive treatment for partial onset seizures in epilepsy patients 12 and up. Adjunctive treatments are to be used with a primary therapy.
The application is supported by data from three late-stage trials conducted mainly in Europe and in the U.S., as well as data from a late-stage trial conducted mainly in Asia.
Epilepsy is categorized by seizure type, with partial onset seizures accounting for about 60% of epilepsy cases and generalized seizures for 40%. In a partial-onset seizure, an abnormal disturbance occurs in a limited area of the brain and may spread to become a generalized seizure. In a generalized seizure, disturbances occur throughout the brain and can be followed by a loss of consciousness.
In China, about 9 million people have epilepsy with about 60% impacted by partial onset seizures. Of those being impacted by partial onset seizures, about 40% need adjunctive treatment.
Fycompa, also known as perampanel, is approved in over 55 countries as an adjunctive treatment for partial onset seizures. The drug is also approved to help treat primary generalized seizures in over 50 countries. In the U.S., Fycompa can be used as a standalone or as an adjunctive treatment for partial onset seizures.