Uloric Approved for Gout
The first new treatment option in 40 years
MONDAY, Feb. 16, 2009 (HealthDay News) -- Takeda Pharmaceuticals' Uloric (febuxostat) has been approved by the U.S. Food and Drug Administration to treat gout, a painful condition characterized by elevated levels of uric acid that can build up in the blood, joints and soft tissue.
Uloric is the first new treatment option in more than four decades for gout, a chronic condition affecting more than 5 million Americans, the Japanese drug maker said in a news release. It's the most common inflammatory arthritis in men 40 and older.
The FDA approved the drug in 40 mg. and 80 mg. strengths. Takeda initially requested approval for 80 mg. and 120 mg versions, but the agency was concerned about possible cardiovascular side effects stemming from the higher doses, the Bloomberg news service reported.
Uloric was evaluated in clinical trials involving more than 4,000 people. The most common side effects reported were liver function abnormalities, nausea, joint pain and rash.
The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about gout.