China approves Eisai’s Fycompa for partial onset epileptic seizures

pharmafile | October 16, 2019 | News story | Research and Development, Sales and Marketing China, Eisai, Fycompa, epilepsy, pharma 

Tokyo-headquartered firm Eisai has announced that its antiepileptic drug (AED) Fycompa (perampanel) has received approval from China’s National Medical Products Administration (NMPA) for the adjunctive treatment of partial onset epileptic seizures(with or without secondarily generalised seizures) in patients over the age of 12.

The decision, awarded under the Administration’s Priority Review pathway in just over 12 months, was based on data from a number of Phase 3 studies which indicated that Fycompa reduced seizure frequency by 17.3%, 29% and 38.9% in its 4, 8 and 12mg formulations respectively, compared to 10.8% with placebo.

A separate trial also demonstrated that the therapy produced at least a 50% or greater reduction in seizure frequency in 37.6% of patients in the 8mg and 36.1% in the 12mg group, compared to 26.4% with placebo, met its primary endpoint.  

An estimated nine million Chinese citizens live with epilepsy, and around 60% of this number are affected by partial-onset seizures. Of this group, around 40% require adjunctive treatment, and around 30% of the total number of epilepsy patients in the country cannot control their seizures with the use of currently available AEDs.   

Matt Fellows

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