Is Etrasimod-Velsipity already on the market in China and its clinical use instructions

Etrasimod (trade name Velsipity) is an oral small molecule selective S1P1 receptor modulator. It mainly regulates the migration of peripheral blood lymphocytes into the intestine, thereby reducing the inflammatory response. It is designed to treat patients with moderately to severely active ulcerative colitis (UC), especially those who have had an inadequate response to or poor tolerance to conventional treatments such as glucocorticoids, immunomodulators, or biologics. By inhibiting the migration of lymphocytes to the intestinal mucosa, itrimod can effectively relieve inflammation, improve mucosal healing and reduce clinical symptoms.

Clinical studies have shown that Itrimod tablets have good efficacy and safety in patients with moderate to severe ulcerative colitis. In randomized controlled trials, after patients were treated with 2 mg or 1 mg daily doses of itrimod tablets, the remission rate was significantly higher than that of the placebo group, and the mucosal healing rate was also significantly improved. The drug is convenient to take orally and can be administered once a day, and the patient's compliance is high. For patients with recurrent or refractory enteritis symptoms, itridimod can be used as part of a maintenance treatment program to maintain clinical remission through long-term use.

Itramod tablets were approved for marketing by the US FDA in 2023 10 month, but it has not yet been launched in mainland China and has not been included in the medical insurance catalog. This means that domestic patients cannot obtain original drugs through formal channels in hospitals or pharmacies, and must wait for future launches or policy inclusion before they can be used under the domestic formal medical system. Since there are no approved generic drugs in China, if patients consider purchasing drugs through overseas channels, they should fully understand the legality of the channels, the authenticity of the drugs and transportation conditions, and use them under the guidance of professional doctors to ensure drug safety.

In terms of price, there are European and American versions of original drugs in foreign markets. The price of each box of the European version may range from 10,000 to 30,000 yuan, while the price of the American version is slightly higher. Due to differences in exchange rates and channels, the specific cost will fluctuate. Since there are no generic drugs on the market yet, domestic patients who import drugs by themselves or purchase drugs overseas will have to bear high drug costs and cross-border transportation risks. At the same time, long-term treatment may involve multiple courses of medication, resulting in a greater overall economic burden. In clinical use, medical advice should be strictly followed, blood routine, liver function and electrocardiogram should be monitored regularly, and possible adverse reactions should be paid attention to, such as headache, upper respiratory tract infection, abnormal liver function or mild heart rhythm changes.

Overall, itridimod tablets provide a new oral treatment option for patients with moderate to severe ulcerative colitis, with the potential to improve symptoms, promote mucosal healing, and maintain clinical remission. However, it is not yet on the market in China and its use is restricted. Patients need to comprehensively consider the efficacy, risks and costs under the guidance of a professional doctor, and carefully evaluate whether to obtain the drug through overseas channels. In the future, if it is officially launched in China and included in medical insurance, its accessibility and economic burden will be significantly improved, providing new treatment opportunities for more UC patients.

References:https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-velsipity