非布索坦在国内上市的时间

When was it launched? Recently, a patient asked anxiously, let’s find out. Febuxostat was developed in Japan in 2004, and was approved for marketing by European EMEA in 2008, the US FDA in 2009, and the State Food and Drug Administration of China in 2013.

A multicenter, double-blind, randomized phase II clinical study evaluated the safety and efficacy of febuxostat in gout. A total of 136 male and 17 female gout patients were randomly assigned to receive placebo or this product (40, 80 or 120 mg/d). After 4 weeks, tests found that the serum uric acid concentration of patients in each dose group of this product was significantly lower than before treatment. According to the dose, each group decreased by an average of 37%. %, 44% and 59%, while the patients in the placebo group only decreased by 2%; the vast majority of patients persisted in completing the trial. The incidence of adverse reactions in this product and the placebo group was similar, and most of these adverse reactions were mild and self-limiting, with common ones including diarrhea, pain, back pain, headache and joint pain. 

A phase III clinical trial compared the efficacy of this product (80 and 120 mg/d) with that of allopurinol (300 mg/d). A 1-year study of 760 patients showed that compared with the allopurinol group, more patients in the this product group achieved the main trial efficacy indicator - the sUA concentration was measured below 60 mg/L in the last 3 months (all subjects were gout patients, and the sUA concentration before the test were all above 80 mg/L); after 52 weeks of treatment, this product failed to significantly reduce the area of tophi (tophi is unique to gout) aggregates of urate crystals), but in the high-dose group in the early stages of the trial, this effect was more obvious; in each treatment group, patients with sUA concentrations reaching the target (<60 mg/L) were less likely to have gout attacks, and their tophi area was more significantly reduced; adverse reactions and their incidence rates were similar in each treatment group, including abnormal liver function, diarrhea, headache, joint-related signs and symptoms, and musculoskeletal/connective tissue symptoms.

To sum up, febuxostat was approved for marketing by European EMEA in 2008, the US FDA in 2009, and the State Food and Drug Administration of China in 2013. And the effect is ideal, patients can buy it with confidence.