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news.Takeda Pharmaceutical Company and its wholly owned subsidiary, Takeda Global R&D Center, have announced that the Arthritis Advisory Committee of the FDA has recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout.
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The vote was 12 to zero in favor of approval, with one panel member abstaining. If approved in the US by the FDA, febuxostat will be the first new treatment for the management of hyperuricemia associated with gout in more than 40 years. The FDA will review the current new drug application for febuxostat and make its approval decision. The FDA’s decision may or may not follow the committee’s recommendation.
Febuxostat is a potent non-purine, selective inhibitor of xanthine oxidase, which was studied for its ability to lower levels of serum uric acid in patients with hyperuricemia associated with gout. In clinical trials, febuxostat 40mg and 80mg were shown to be effective treatments for the management of hyperuricemia associated with gout. Both doses were well tolerated and required no dose adjustments in patients with renal impairment, the company said.
Nancy Joseph-Ridge, president of Takeda Global R&D, said: Takeda is committed to developing innovative therapies that fulfill unmet treatment needs, and we believe febuxostat will represent an important new option for patients who suffer the debilitating effects of gout. In the coming months, we will work with the FDA to complete their review, including the design of post-marketing studies.