Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients...( DEERFIELD Ill. and OSAKA Japan Nov. 2...),Health

DEERFIELD, Ill., and OSAKA, Japan, Nov. 24 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostatfor the treatment of hyperuricemia in patients with gout. The vote was 12 to zero in favor of approval, with one panel member abstaining. The vote followed presentations by Takeda Global Research & Development Center, Inc., the FDA, and invited guest speakers. If approved in the United States 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.

"Today's vote by the Arthritis Advisory Committee, recommending approval of febuxostat for the treatment of hyperuricemia in patients with gout, is a positive step in bringing this new treatment to market," said Nancy Joseph-Ridge, MD, president, Takeda Global Research & Development, Inc., U.S. "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."

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. Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis. In clinical trials, febuxostat 40 mg and
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