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According to the drug approval documents issued by China's State Drug Administration (NMPA) on December 7, UCB's application for a new adaptive solution for the injection of zuctrasitan has been approved in China.
according to public information, the drug was approved for the treatment of partial seizures in adults and children over 4 years of age with epilepsy.
screenshot Source: NMPA's official website, Left Irassetan (trade name: CapeLand) is an anti-epileptic drug developed by Yosepbi.
The drug is a pyridoxine derivative, the mechanism of action is mainly combined with the special subject synactoid vesicle protein SV2A in the brain, has central selectivity, through participation in the polymerization of vesicles and cell spitting to regulate the release of neurotransmitters and play a role.
, which was first listed in the U.S. as a tablet in 1999, was approved by the FDA in 2008 and is now considered a gold standard drug for epilepsy treatment.
public information shows that since its approval in China in 2007, Ukip has been approved several times to treat patients with different epilepsy: in 2007, zoethylacetam tablets listed in China, mainly used in adults and children over 4 years of age with partial sexual seizures of the treatment; Liquid is listed in China for the use of supplemental treatment for partial seizures in adults, children and infants with epilepsy of more than one month, and in August 2017, the left ethyl laxitan needle was successfully approved in China for the use of supplemental treatment for partial seizures (accompanied or not accompanied by secondary comprehensive seizures) in adults and children over 4 years of age, who are temporarily unable to apply oral preparations to replace the drug.
is worth mentioning that this is also china's only listed original research anti-epileptic needle in 20 years.
. In May 2018, the left ethyl laxitam tablet was approved in China for the use of supplemental treatment for all-round strong-straight seizures in adults and adolescents over 16 years of age.
. In August 2018, China's State Drug Administration again approved the listing of the left ethyl iracetam tablet for the treatment of partial seizures (accompanied or not accompanied by secondary comprehensive seizures) in patients with epilepsy in adults and children over 4 years of age.
According to the website of the Drug Review Center (CDE) of the State Drug Administration of China, this approval is for the treatment of partial seizures (accompanied or not accompanied by secondary comprehensive seizures) in patients with epilepsy in adults and children over 4 years of age.
april this year, the application was included in the CDE's priority review.
screenshot Source: CDE epilepsy is caused by a group of nerve cells in the brain being activated uncontrolled.
seizures can lead to uncontrollable limb movements, abnormal thinking and behavior, and abnormal perception.
the patient's limb movements can be very intense and lead to loss of consciousness.
childhood epilepsy is a complex disease that can have a significant impact on children's development and function, and is a serious neurological disease common in children and young people, and patients are in urgent need of new treatment options.
: China's State Drug Administration on December 7 drug approval documents to be received information. Retrieved Dec 7,2020, from Official Public Source: Medical Mission Hills