Eisai’s Fycompa for Adjunctive Treatment of Partial Onset Seizures Launched in China

New Delhi, January 07, 2019: Eisai Co., Ltd. has launched the in-house discovered and developed antiepileptic drug (AED) Fycompa, (generic name perampanel) for use in the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in epilepsy patients 12 years of age and older.

In China, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60% of whom are affected by partial-onset seizures. About 40% of patients with partial-onset seizures require adjunctive treatment(1). As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs(2), this is a disease with significant unmet medical needs. Fycompa was designated for Priority Review by the National Medical Products Administration due to its significant clinical benefits compared to existing treatments after the submission in September 2018 and was approved on September 29, 2019.

Fycompa is a first-in-class AED and a once-daily tablet discovered at Eisai’s Tsukuba Research Laboratories. In the United States and Europe, a new oral suspension formulation has been approved and is being marketed. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.

Fycompa has been approved in over 65 countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. In addition, Fycompa has been approved in over 60 countries as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In the United States, Fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

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. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

(1) Clinical Guideline 2015 in China.
(2) “The Epilepsies and Seizures: Hope Through Research. What are the epilepsies” National Institute of Neurological Disorders and Stroke, accessed May 24, 2016, https://bit.ly/39BKqDT

Corporate Comm India(CCI Newswire)