Is Brivaracetam available as a drug in China?

Brivaracetam/Brivaracetam is a new anti-epileptic drug that is a selective synaptic vesicle protein 2A (SV2A) binding agent that can regulate neuronal excitability and reduce the frequency of epileptic seizures. Compared with traditional antiepileptic drugs, brivaracetam has the advantages of rapid onset of action, low side effect spectrum, and can be used in combination with other antiepileptic drugs, making it an important choice for the clinical management of partial seizures. However, the original drug of Brivaracetam has not yet been approved for marketing in mainland China, and domestic patients are temporarily unable to directly purchase the original drug through formal channels.

Although Brivaracetam has been sold as an original drug in overseas markets, including the United States, Europe, Japan and other places for many years, and is widely used for the treatment of partial epilepsy in adults and infants, the drug registration and approval process is still in progress in China. When reviewing new anti-epileptic drugs, domestic drug regulatory authorities usually require pharmacokinetics, safety and effectiveness data for the Chinese population to ensure the rationality and safety of the drug's local application. Therefore, the fact that the original drug of Brivaracetam has not yet been launched is not due to safety issues with the drug, but because the approval process and clinical data localization requirements have not yet been completed.

Some domestic pharmaceutical companies may carry out research and development and clinical registration of the domestic original drug of brivaracetam, which will provide patients with more convenient and economical access, and at the same time, cooperate with the application of local clinical guidelines in China to bring new treatment options to epilepsy patients. Prior to this, if domestic patients obtained Brivaracetam through overseas pharmacies or cross-border drug purchases, they still had to strictly follow the doctor's prescription and regulatory policies to ensure drug safety.

Generally speaking, the marketing status of Brivaracetam in China is still "not approved". Patients and their families need to pay attention to the announcements and updates of clinical guidelines from the drug regulatory authorities so that they can be used scientifically when obtaining drugs from regular channels in the future.

Reference materials:https://www.briviact.com/