Eisai's Perampanel Set to Enter China's $700 Million Anti-Epileptic Market

Original: Cai Cai

In the second half of this year, China’s RMB 5 billion antiepileptic drug market will welcome new entrants. According to the official website of the National Medical Products Administration (NMPA), the status of the marketing application for perampanel (brand name: Fycompa) from Eisai, Japan, has been updated to “Under Review.” The author speculates that the drug is highly likely to be approved for launch in October.

(Source: NMPA Official Website)

(Source: NMPA Official Website)

One of Eisai’s Four Flagship Products

Perampanel is a highly selective, non-competitive AMPA-type glutamate receptor antagonist developed by Eisai of Japan. It prevents and treats epilepsy by inhibiting glutamate activity at postsynaptic AMPA receptors, thereby reducing neuronal hyperexcitability.

In October 2012, the FDA first approved perampanel tablets for marketing as adjunctive therapy for partial-onset seizures with or without secondary generalization in patients aged 12 years and older with epilepsy;

In June 2015, the FDA approved an expanded indication for perampanel hydrate as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older. PGTC seizures are among the most severe manifestations of epilepsy, causing significant injury due to sudden falls and representing a major risk factor for sudden unexpected death in epilepsy (SUDEP).

In April 2016, the FDA approved perampanel oral suspension for the treatment of partial-onset seizures with or without secondary generalization and primary generalized tonic-clonic (PGTC) seizures in patients aged 12 years and older with epilepsy.

Perampanel applied for clinical trials in July 2015 and submitted its marketing authorization application in October 2018.

(Source: CDE)

In December 2018, it was included in the priority review by the CDE.

(Source: CDE)

The 5-Billion Anti-Epileptic Drug Market Suffers from a Scarcity of New Drugs, with Domestic Options in Short Supply

Epilepsy is one of the three major diseases of the human central nervous system and one of the oldest and most typical conditions in medical history, with an incidence rate even higher than that of presenile dementia. In China, the incidence of epilepsy is relatively lower, with an overall prevalence of approximately 7%, which is close to the 7.2% incidence rate observed in developing countries. Due to the large population base, nearly 10 million epilepsy patients in China require appropriate treatment, including over 6 million who experience seizures. With more than 400,000 new cases diagnosed annually, strengthening the development of antiepileptic drugs remains a significant priority both domestically and internationally.

In 2017, the International League Against Epilepsy (ILAE) launched a new classification system for epileptic seizures and epilepsy. This new system, introduced 35 years after the previous classic classification system, represents a major innovation in the field of epilepsy.

According to Wind sample hospital data, the market for antiepileptic drugs in domestic sample hospitals reached RMB 1.406 billion in 2018, a year-on-year increase of 8.33%. Based on this calculation, the national market for antiepileptic drugs across public medical institutions and retail pharmacy terminals in China approached RMB 5 billion in 2018.

Sales of Anti-Epileptic Drugs in Sample Hospitals in China, 2013–2018

(Source: Wind)

The top three antiepileptic drugs in the market are levetiracetam, sodium valproate, and oxcarbazepine. These three form a tripartite balance, accounting for approximately 60% of the market share. All three are imported medications that have been approved for many years. Currently, China's antiepileptic drug market is characterized by a scarcity of new drugs and a shortage of domestically produced options.

Among them, levetiracetam holds a market share of 23.73%. The top 10 products are levetiracetam tablets, sodium valproate for injection, oxcarbazepine tablets, sodium valproate sustained-release tablets, lamotrigine tablets, pregabalin capsules, magnesium valproate tablets, gabapentin capsules, topiramate tablets, and levetiracetam oral solution.

Top 10 Antiepileptic Drugs in Sample Hospitals in China, 2018

(Source: Wind)