Eisai's anti-epileptic drug receives 2 additional approvals from the National Food and Drug Administration

Eisai recently announced that its internally discovered and developed anti-epileptic drug Fycompa (Weiketai®, generic name: perampanel, perampanel) has received two additional approvals from the National Medical Products Administration (NMPA) of China : (1) As a single-drug therapy for the treatment of partial-onset epilepsy; (2) Pediatric indications: As an adjuvant therapy/monotherapy, used for the treatment of partial-onset epilepsy in pediatric epilepsy patients ≥ 4 years old

In China, Fycompa (Weiketai) has been approved before: adjuvant treatment of partial-onset epilepsy (with or without secondary generalized seizures) in patients with epilepsy ≥12 years of age

It is estimated that there are about 9 million patients with epilepsy in China, about 60% are affected by partial-onset epilepsy, and 40% of those with partial-onset epilepsy require adjuvant treatment

The approval of Fycompa monotherapy for partial-onset epilepsy is based on the results of a subgroup analysis of Fycompa as an adjuvant therapy (Studies 304, 305, 306, 335) evaluating the safety and effectiveness of monotherapy

The approval of Fycompa pediatric patients with partial-onset epilepsy is based on the results of a Phase 3 clinical study (Study 311)

Perampanel chemical structure (picture source: adooq.

Fycompa is a first-in-class antiepileptic drug (AEDs) developed internally by Eisai.

As of now, Fycompa has been approved by more than 70 countries around the world, including Japan, the United States, China, and other countries in Europe and Asia, as an adjuvant therapy for partial-onset epilepsy (POS, with or No secondary generalized seizures) treatment

In terms of medication, Fycompa is taken orally once a day before going to bed.

In China, Fycompa (Generic name: perampanel, perampanel) submitted a new drug application (NDA) in September 2018 as an adjuvant therapy for partial-onset epilepsy in patients with epilepsy 12 years and older

In early January 2021, Eisai launched Fycompa (Weiketai®) in the Chinese market, which is a once-daily tablet for partial-onset epilepsy (with or without secondary Generalized epilepsy) adjuvant treatment

Epilepsy can be roughly classified according to the type of seizure.

Epilepsy (epilepsy) is one of the most common neurological diseases in the world.

Original source: ANTI-EPILEPTIC DRUG FYCOMPA APPROVED IN CHINA AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES AND PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES