Eisai Co. Ltd. said its epilepsy treatment Fycompa, or perampanel, won regulatory approval from the National Medical Products Administration to market the drug in China.
The drug is now approved as an adjuvant treatment for partial onset seizures in epilepsy patients aged 12 and above, the Japanese company said in a release dated Oct. 15. Partial seizures occur when abnormal electrical activity happens in only one part of the brain.
Eisai submitted the application for the drug in September 2018 and was granted priority review by the Chinese regulator.
China has approximately 9 million patients with epilepsy, and 60% are affected by partial-onset seizures. About 40% of patients with partial-onset seizures require adjuvant treatments.
Fycompa has received regulatory approval in more than 60 countries as an adjuvant treatment for partial-onset seizures in patients with epilepsy aged 12 and above, Eisai said in the release.
The drug is also approved in over 55 countries as an adjuvant treatment for primary generalized tonic-clonic seizures in patients with epilepsy. Generalized tonic-clonic seizure is a type of seizure that usually occurs on both sides of the brain, or start on one side and spread to the whole brain.