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(Vigabatrin tablets) was first approved by the US FDA for the treatment of infantile spasms on August 21, 2009, making it the first drug to treat this disease in the US market. In addition, the drug can also be used as an auxiliary treatment for adult patients with complex partial epilepsy (CPS), a condition that currently cannot be effectively controlled by commonly used anti-epileptic drugs. Vigabatrin exerts a therapeutic effect by increasing the level of gamma-aminobutyric acid in the brain. It was first approved in the UK 20 years ago as an auxiliary drug for general epilepsy. It was first applied for in the United States 15 years ago but was not approved for marketing until later due to safety issues.

Vigabatrin was approved based on the results of two randomized, controlled trials named 1A and W019. Study 1A evaluated the safety and efficacy of vigabatrin in 221 subjects under 2 years old, all of whom were diagnosed with infantile spasms within 3 months before the start of the study. The study showed that the efficacy of short-term use of vigabatrin was dose-dependent.

The W019 study was conducted in 40 patients and was designed to evaluate the persistence of the efficacy of Vigabatrin as a first-line treatment. Compared with the placebo group, the average daily frequency of cramps in the Vigabatrin group was reduced more during the preset 2-hour monitoring window after administration (54% vs. 41.5%), but there was no statistical difference between the two groups. As the 14th largest pharmaceutical company, Sanofi is very keen on establishing the company's product position, and its main sales activities are concentrated in the United States.

Sanofi is currently on the market in the United States and many European countries and regions, and patients in need can purchase the medicines they need in these listed countries and regions. Unfortunately, the drug has not been approved for domestic marketing so far, so patients can only meet their treatment needs by purchasing drugs overseas. When actually purchasing medicines, patients can contact some professional and formal overseas medical service organizations in China (such as Medical Companion Travel) to obtain purchase channels.

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