非布索坦获批适应症

The U.S. FDA has approved the first gout drug in the past 40 years to treat hyperuricemia—Takeda Pharmaceutical’s (febuxostat; ULORIC). Febuxostat improves gout symptoms by lowering uric acid levels in the patient's blood. In addition, Takeda Pharmaceuticals North America is the independent developer and marketer of this product in the U.S. market.

According to a statement from Takeda: The structure of this product is completely different from the xanthine oxidase inhibitor drugs developed 40 years ago. It is a new and highly effective non-purinic xanthine oxidase selective inhibitor. Xanthine oxidase is the key enzyme that promotes the production of uric acid.

Febuxostat can reduce uric acid levels in the blood of patients with hyperuricemic gout. The safety and effectiveness of Febuxostat have been proven in clinical studies, and no dose adjustment is required in patients with moderate or severe hepatic and renal insufficiency. The dosage of this product is 40 mg or 80 mg once daily, but this product is not recommended for patients with gout who do not have hyperuricemia.

The original manufacturer of Febuxostat is another Japanese company, Teijin Pharma. In a recent statement from the president of Teijin Pharmaceuticals, we can learn about the company's global strategy for the product. He said that before this product was approved by the FDA, Ipsen's product also obtained marketing authorization from the European Union. Ipsen is Teijin Pharmaceutical's license company for this product in the EU, while Takeda North America Pharmaceuticals is the license company for this product in the United States. Therefore, the company has achieved a strategic milestone globally. At the same time, he also pointed out that in the Asian market, Teijin Pharmaceutical will adopt the form of independent development or joint development.

According to experts, gout is a group of heterogeneous diseases that are caused by reduced uric acid excretion and/or purine metabolism disorders that are inherited and/or acquired. Clinical features: hyperuricemia, as well as characteristic acute arthritis, tophi, interstitial nephritis, joint deformity and dysfunction caused by urate crystal deposition in severe cases; often accompanied by uric acid urinary tract stones. Pseudogout is often confused with gout because its symptoms are very similar. Pseudogout is caused by a disorder of calcium phosphate metabolism rather than a disorder of uric acid metabolism. The emergence of the drug has provided a powerful weapon for gout patients to fight against the disease!