Eisai's New Drug Fycompa® Approved by China's National Medical Products Administration for Adjunctive Treatment of Epilepsy

TOKYO, Oct. 17, 2019 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; “Eisai”) announced that China’s National Medical Products Administration (NMPA) has approved Eisai’s new drug FYCOMPA® for adjunctive therapy in adult and pediatric patients aged 12 years and older with partial-onset seizures (with or without secondary generalized seizures). Since the submission of the New Drug Application in September 2018, FYCOMPA® was granted priority review status by the NMPA due to its significant clinical benefits compared to existing treatments, and approval was obtained approximately 12 months later.

There are approximately 9 million epilepsy patients in China, of whom about 60% are affected by focal seizures, and 40% of those with focal seizures require adjunctive therapy. Approximately 30% of epilepsy patients fail to achieve seizure control with existing antiepileptic drugs. Epilepsy is a disease with significant unmet medical needs.

Viekta® is an innovative antiepileptic drug developed by Eisai Tsukuba Research Laboratories, administered orally once daily. It is a highly selective, non-competitive AMPA receptor antagonist that reduces the hyperexcitability of neurons associated with seizures by targeting and inhibiting glutamate activity at postsynaptic membrane AMPA receptors.

VIMPAT® has been approved in more than 60 countries worldwide for adjunctive treatment of partial-onset seizures (with or without secondary generalized seizures) in patients aged 12 years and older with epilepsy. Additionally, VIMPAT® has been approved in 55 countries globally for adjunctive treatment of primary generalized tonic-clonic seizures in patients aged 12 years and older with epilepsy. In the United States, VIMPAT® is approved for monotherapy and adjunctive treatment of partial-onset seizures (with or without secondary generalized seizures) in patients aged 4 years and older with epilepsy.

Eisai regards neuroscience, including epilepsy, as a key therapeutic area. With the approval of VICTOBIL® in China, Eisai is committed to meeting the diverse needs of patients with epilepsy and their families, and enhancing their well-being, in accordance with its mission to free numerous epilepsy patients from the burden of seizures.