The first gout compound drug was approved by the US FDA

On August 22, Ironwood announced that its gout drug Duzallo was approved by the US FDA, which is the first FDA approved gout compound.

It is known that Duzallo is a once-a-day oral fixed-dose combination of a fixed dose of Zurampic (common name lesinurad) and allopurinol, with 200 mg of Zurampic plus 200 or 300 mg of allopurinol, this time Duzallo The approval was based on two key Phase 3 clinical trials evaluating the bioequivalence of a fixed-dose of lesinurad in combination with allopurinol and the two drugs alone. The results showed that the combination of Zurampic and allopurinol was used. The number of people who control the 6 mg/dL was almost doubled compared with the use of allopurinic uric acid alone, and the average sUA level was reduced to below 6 mg/dL in the first month, and this level was maintained for 12 months.

Gout is an inflammatory arthritis caused by high serum uric acid levels, which can lead to pain and serious long-term health consequences. In recent years, with the change of lifestyle and the aging of the population, the incidence of gout has increased, gout Not only are the symptoms obvious, but high uric acid has also been found in recent years to increase the risk of other metabolic and cardiovascular diseases, although some patients can reduce serum uric acid levels by using xanthine oxidase inhibitor (XOI), an allopurinol. However, in the United States, there are approximately 2 million patients who are treated with XOI whose condition cannot be controlled and cannot meet the target serum uric acid level recommended by the American College of Rheumatology - below 6 mg/dL.

It is expected that Duzallo will be available at the end of 2017 with a peak sales of approximately $300 million.

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