卫材抗癫痫新药呲仑帕奈在中国获批新适应症

China's National Medical Products Administration (NMPA) recently announced that the new indication marketing application for the anti-epileptic drug (perampanel, trade name: Victim) developed by Eisai has been approved. According to an earlier press release issued by Eisai, it is speculated that the new indication for parampanel to be approved this time may be: monotherapy for pediatric partial seizures in patients aged 4 years and above.

Epilepsy is a chronic neurological disease caused by abnormal discharges of the central nervous system, with episodic and recurrent characteristics. Excessive activation of nerves during seizures can cause excitotoxic damage. In children and adolescents, long-term and repeated epileptic seizures that are difficult to control can cause cognitive impairment, behavioral and mental health problems, and seriously affect the patient's quality of life. It is more important to control seizures as early as possible.

Garampanel is the first highly selective, non-competitive AMPA glutamate receptor antagonist targeting α-amino-3-hydroxy-5-methyl-4-isoranoxazole propionic acid (AMPA) receptor 2. It can selectively inhibit the increase in Ca2+ induced by AMPA and reduce the over-excitation of nerves. It is clinically used in combination with other anti-epileptic drugs to treat focal epilepsy.

There are currently some international observational studies on the effectiveness and tolerability of parampanel in the pediatric population. Biro et al. reported a retrospective study of 58 patients with refractory epilepsy aged 2 to 17 years old; the 50% response rate after 3 months of treatment was 31%, and 8.6% of patients had complete seizure control. The results of an Italian multicenter observational study showed that 62 pediatric patients were followed up for an average of 6.6 months, the effective rate was 50%, and the seizure-free rate was 4.8%.

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.