Febuxostat Receives FDA Approval

There's news for those who suffer from gout: The FDA has approved a gout treatment, already in use in Europe, that lowers uric acid blood levels. This is the first new drug on the U.S. market in more than 40 years. The new drug febuxostat will be marketed under the name Uloric, by Takeda Pharmaceuticals North America, the developer and only pharmaceutical company licensed to sell this product in the United States.

Potent Inhibitor

Takeda issued a statement saying that febuxostat is very potent against xanthine oxidase, but has little resemblance to the xanthine oxidase inhibitor in current use, which was developed more than four decades ago. Uric acid production relies in large measure on the enzyme xanthine oxidase. Febuxostat serves to lower the amount of uric acid in the blood of gout patients who have excessive amounts of the crystal-producing acid in their blood.

Clinical trials have proven the drug to be both safe and effective and there does not appear to be any need to adjust the dose for those patients with liver impairment or mild to moderate kidney failure. Uloric will be made available in 40 and 80 milligram tablets to be taken as a single daily dose. Takeda's press release cautions that Uloric is not intended for patients with high blood levels of uric acid who don't exhibit gout symptoms.

Febuxostat was developed by the Japanese company, Teijin Pharma, whose president, Osamu Nishikawa stated in the joint press release between Teijin Pharma and Takeda, "This FDA approval granted to Takeda Pharmaceuticals North America, along with the EMEA [European Medicines Agency] approval given last year to Ipsen, our licensee for febuxostat in Europe, marks a significant milestone for our global business."

Global Market

Nishikawa commented that Teijin was working on developing febuxostat for the Asian market and also on working together with other pharmaceutical companies. Teijin hopes to expand its operations in the global market by bringing febuxostat to other areas so that it can be made available to gout patients all over the world.

Yasuchika Hasegawa, president of the parent company for Takeda in Japan stated, "The approval of ULORIC offers patients and healthcare providers in the US for the first time in 40 years, a novel treatment option for patients who have hyperuricemia with gout, where there are still unmet clinical needs."

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) said it believes there may be some 6 million Americans from the ages of 20 and up who suffer from gout at some point in their lives. Gout is more common in men in their 40's and 50's, and most women only get gout after menopause. Those people who have had an organ transplant are the most susceptible to the disease.