FDA Approves First Gout Drug In 40 Years

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Main Category: Gout
Also Included In: Regulatory Affairs / Drug Approvals;  Arthritis / Rheumatology
Article Date: 16 Feb 2009 - 3:00 PDT

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The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda Pharmaceuticals North America is the sole developer and marketer of the product in the US.

According to a statement from Takeda, febuxostat is a new highly potent non-purine selective inhibitor of xanthine oxidase, and has a completely different structure from the currently used xanthine oxidase inhibitor, which was developed over 40 years ago. Xanthine oxidase is an enzyme involved in the production of uric acid.

Febuxostat lowers the concentration of uric acid in the blood of hyperuricemic patients with gout. The drug has been proved to be safe and effective in clinical trials, and the dose does not need to be adjusted for patients with mild-to-moderate renal or hepatic impairment (kidney or liver problems).

ULORIC will be available as 40 mg or 80 mg tablets to be taken once a day. It is not recommended for asymptomatic hyperuricemia, said the company's press release.

Febuxostat was discovered by another Japanese company, Teijin Pharma. Their president Osamu Nishikawa said in a press statement released jointly with Takeda that:

"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."

He said Teijin would be developing febuxostat themselves for the Asian market, as well as collaborating with other pharma companies. The company wishes to strengthen its global operations by "expanding areas where febuxostat is available and increase the presence of the product to be widely used by patients worldwide," he added.

President of the Takeda parent company in Japan, Yasuchika Hasegawa, said:

"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."

Gout is a common, painful form of arthritis that causes swollen, red, hot and stiff joints. It occurs when uric acid builds up in the blood, because the body produces too much or can't get rid of it (some medications can slow down elimination), or from eating too many foods rich in purines, such as liver and dried beans.

Pseudogout is sometimes confused with gout because the symptoms are similar; however, it is caused by calcium phosphate, not uric acid.

According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), there could be as many as 6 million Americans aged 20 and older who have had gout at some time in their lives. It is more common in men aged 40 to 50, and women rarely develop it before the menopause. Also people who have had an organ transplant are more susceptible.

NIAMS suggest people may be at risk of developing hyperuricemia and gout if they are on certain medications, these include:

• Diuretics, such as furosemide (Lasix1), hydrochlorothiazide (Esidrix, Hydro-chlor), and metolazone (Diulo, Zaroxolyn).


• Drugs containing salicylate, such as aspirin.


• Niacin, a vitamin also known as nicotinic acid.


• Cyclosporine (Sandimmune, Neoral), a medication used to suppress the immune system.


• Levodopa (Larodopa), a drug used in the treatment of Parkinson's disease..

Takeda Pharmaceuticals North America, Inc, whose head office is in Deerfield, Illinois, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited whose head office is in Chuo-ku, Osaka, Japan.

Sources: Takeda Pharmaceutical Company Limited press release, NIAMS.

Written by: Catharine Paddock, PhD


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