Fda Approves Takeda Pharm's Uloric

Uloric is a prescription medicine called a xanthine oxidase inhibitor that reduces the production of uric acid in your body.

Uric acid buildup can lead to gout or kidney stones.

Uloric is used to treat high blood concentrations of uric acid in patients with gout.

The FDA has approved Uloric, the first new gout drug in more than 40 years, according to Uloric's maker, Takeda Pharmaceuticals.

Uloric, taken once daily by mouth, is approved for the chronic management of hyperuricemia (elevated levels of uric acid) in gout patients.

Uloric works by blocking an enzyme called xanthine oxidase, which helps prevent uric acid production, lowering elevated uric acid levels, according to Takeda.

In 2005, the FDA refused to approve Uloric because there were slightly more deaths and heart problems in patients taking the drug than in patients taking allopurinol, another gout drug. As people with gout problems already are at higher risk of heart disease, the FDA issued an "approvable" letter, noting that Uloric could be approved if this safety question were addressed.

What Is Uloric?

Uloric is a drug used for the chronic management of hyperuricemia in gout. While it was in clinical trials, Uloric was known by its generic name, febuxostat.

How Does Uloric Work?

Uloric lowers serum uric acid levels by blocking xanthine oxidase -- the enyzme responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine (a natural-occurring purine derivative) to xanthine, and then to uric acid.

How Is Uloric Given?

The approved doses of Uloric are 40 mg and 80 mg to be given once daily. Uloric is an oral medication (taken by mouth).

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC(R) (febuxostat) 40 mg and 80 mg for the chronic management of hyperuricemia in patients with gout. This once-daily, oral medication is the first new treatment option in more than 40 years for the more than five million patients who have hyperuricemia associated with gout. ULORIC was discovered by Teijin Pharma Limited (Teijin Pharma) of Tokyo and licensed to Takeda for the U.S. market.