Fycompa is a first in class anti-epileptic drug (AED) discovered and developed by the pharmaceutical company, Eisai and it’s ready to be marketed in China. The drug is used to supplement the treatment of partial-onset seizures in epilepsy patients 12 years of age and older.
In China alone, there are over nine million patients with epilepsy with approximately 60% suffering from partial-onset seizures. 30% of patients suffer from drug resistant epilepsy and are unable to control their seizures. Fycompa was designated for Priority Review by the National Medical Products Administration due to its promising clinical trials, compared to other existing AED treatments.
The approval of Fycompa in China was based on the results of Phase III clinical study conducted in Japan, China, Korea, as well as the results of three Phase III clinical studies conducted in Europe and the United States.
The study was conducted to evaluate the efficacy and safety of Fycompa mainly for the patients in the Asia region. The primary endpoint of the study was the percentage change in seizure frequency with over 50% of patients in Europe and the United States a greater reduction in seizure frequency.
Fycompa has already been approved in over 65 countries around the world as a supplementary treatment for partial-onset seizures and has been approved in 60 countries for generalised tonic-clonic seizures. To date, Fycompa has been used to treat more than 270,000 patients worldwide.
The new oral suspension formulation has already been approved and marketed in the United States and Europe. The once-daily tablet reduces neuronal hyperextension associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.
Eisai considers neurology including epilepsy, a therapeutic area of focus. With this launch of Fycompa in China, Eisai pursues our mission to provide “seizure freedom” to a greater number of patients with epilepsy across the world.