【重磅】百万抗癫痫患者新希望:呲仑帕奈在国内获批！

Epilepsy is a chronic non-communicable disease of the brain that affects approximately 50 million people worldwide, making it one of the most common neurological diseases worldwide. It is a better drug for the treatment of epilepsy. In October 2019, Eisai announced that the State Food and Drug Administration had approved its new anti-epileptic drug perampanel (Weiketai) for the add-on treatment of partial-onset epilepsy patients (with or without secondary generalized seizures) in adults and children aged 12 years and above. This means that China’s epilepsy treatment field has officially welcomed the first non-competitive AMPA receptor antagonist, which will bring new treatment methods and means to epilepsy patients and their families.

In November 2020, the European Commission (EC) approved the anti-epileptic drug perampanel to expand its applicable population:

(1) As adjuvant therapy for the treatment of patients with partial-onset epilepsy (POS, with or without secondary generalized seizures), the age range is expanded from 12 years and above to 4 years and above;

(2) As adjuvant therapy for patients with primary generalized tonic-clonic epilepsy (PGTCS), the age range is expanded from 12 years and above to 7 years and above.

An experimental study evaluated parampanel as adjuvant therapy in pediatric patients with POS or PGTCS.

(1) Study 311 evaluated the safety, tolerability, efficacy and blood concentration of garampanel as an adjuvant therapy for the treatment of pediatric patients (aged 4 to less than 12 years old) with inadequately controlled POS or PGTC. The results of this study indicate that the safety and efficacy of parampanel combination therapy in pediatric patients (aged 4 to less than 12 years old) with poorly controlled POS are similar to those in patients 12 years and older. The most common adverse events (incidence ≥10%) observed in this study were somnolence, nasopharyngitis, pyrexia, vomiting, dizziness, influenza, and irritability.

(2) Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of parampanel as adjuvant therapy in pediatric patients with epilepsy (age 2 to less than 12 years old). Adverse events observed in this study (≥10% in the garampanel group) were pyrexia, fatigue, vomiting, irritability, drowsiness, dizziness, and upper respiratory tract infection.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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