Eisai, a Japanese pharmaceutical company, recently announced the launch of a new generation of antiepileptic drug in China, fycompa ® (general name: pirampanel), which is a tablet taken once a day for the adjuvant treatment of partial epilepsy (with or without secondary systemic epilepsy) in patients aged 12 and over. The new drug application (NDA) of fycompa was submitted in September 2018. Due to its significant clinical benefits with existing drugs, the National Drug Administration of China (NMPA) granted the priority qualification of fycompa in January 2019 and approved fycompa in September 2019.
It is estimated that there are about 9 million epileptics in China, about 60% of them are affected by partial epilepsy, and 40% of them need adjuvant treatment. About 30% of epileptic patients received AEDs which were available on the market and could not control epileptic seizures, so there was a significant unmet medical demand in this field.
Fycompa is a first in class antiepileptic drug (AEDs) developed by Eisai, which is a tablet taken once a day. In the United States and the European Union, a new oral suspension formulation, fycompa, has been approved for marketing. Fycompa is a highly selective and non competitive glutamate receptor antagonist of AMPA type. Glutamate is the main neurotransmitter of epilepsy. As an AMPA receptor antagonist, fycompa can reduce the hyperactivity of epilepsy related neurons by targeting the activity of postsynaptic AMPA receptor glutamate, which is different from the current market antiepileptic drugs (AEDs).
Up to now, fycompa has been approved by more than 60 countries in the world. As an adjuvant therapy, fycompa is used for the treatment of partial epilepsy (POS, with or without secondary systemic epilepsy) in patients aged 12 and over. In addition, fycompa has also been approved by more than 60 countries in the world as an adjuvant therapy for the treatment of primary generalized tonic clonus (PGTC) seizures in epileptic patients aged 12 and over. In the United States, fycompa is also suitable as a single drug therapy and adjuvant therapy for partial epilepsy (with or without secondary systemic epilepsy) in patients aged 4 years and over. At present, Weicai is also carrying out a global phase III clinical study (study 338) to evaluate the treatment of Lennox Gastaut syndrome related epilepsy with fycompa.
Epilepsy is one of the most common neurological diseases in the world. There are about 3.4 million patients in the United States, 1 million in Japan, 6 million in Europe, 9 million in China and 60 million in the world. About 30% of patients can't control their condition with AEDs, so there is a huge medical demand in this field.
Epilepsy can be roughly classified according to its seizure types, in which partial seizures account for about 60% of epileptic cases and systemic seizures account for about 40%. Primary generalized tonic clonic (PGTC) seizures, or grand mal, are the most common and severe types of generalized seizures, accounting for about 60% of the total seizure cases. Pgtc seizures are characterized by loss of consciousness and general convulsions. The main symptoms of major epileptic seizures are foaming at the mouth, eyes turning up, limbs twitching, screaming and so on, which can cause incontinence of stool and urine and persistent seizures. Epilepsy is the result of the imbalance of brain neurons' stimulation and inhibition. These imbalances may be caused by a variety of neurochemical mechanisms, but little is known at present. (The original source https://www.eisai.com/news/2020/news202001.html, compiled by www.hsppharma.com)