Product introduction and launch development track of Pegloticase

Pegloticase is a biological agent with the trade name Krystexxa®. It was developed by Savient Pharmaceuticals in the United States and later acquired by Horizon Therapeutics. It is the first and only recombinant uricase drug for the treatment of refractory chronic gout, especially for patients who are ineffective or intolerant to traditional urate-lowering drugs (such as allopurinol and febuxostat).

Pegloticase is a PEG recombinant urate oxidase. Its mechanism of action is to convert uric acid that cannot be metabolized by the body into allantoin that is easier to excrete, thereby significantly reducing serum uric acid levels. This mechanism is different from traditional drugs. It is currently the only drug that can quickly and significantly reduce uric acid and dissolve tophi. It is suitable for patients with obvious gout nodules and severely affected joints.

The drug was approved by the U.S. Food and Drug Administration (FDA) in 2010 and has become a new treatment for refractory gout. Its launch has broken the long-term dependence on oral urate-lowering drugs for gout treatment, and has shown good efficacy especially in patients with gout nodules, recurrent attacks, and joint deformities.

CurrentlyPegloticase has been approved for marketing in many countries and regions such as the United States, Europe, and Canada. However, because it is an intravenous injection preparation, it is expensive and has a high risk of adverse reactions, so it has not been widely used worldwide. Mainland China has not yet approved the drug for marketing, but some medical institutions may obtain it through licensed import channels.

With a deeper understanding of the pathological mechanisms of gout, Pegloticase is being incorporated into more comprehensive gout management strategies, and studies are exploring its combination with immunosuppressants to extend the duration of efficacy and reduce immunogenicity.

Reference materials:https://en.wikipedia.org/wiki/Pegloticase

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