The FDA arthritis advisory committee has recommended the approval of Uloric for the treatment of gout. Uloric, the name that has been given to generic Febuxostat, was recommended by a 12-0 vote (one member of the committee abstained). If approved, Uloric would become the first drug in 40 years approved to specifically treat gout.
Uloric works by reducing levels of uric acid. About one-third of the uric acid in our bodies comes from the food we eat -- the rest we produce ourselves through ordinary metabolism. When levels of uric acid are elevated in the blood, it can lead to the formation of needle-like crystals that can become deposited in the joints causing gout -- an intensely painful condition.
Early on there were concerns that clinical trials of Uloric showed a higher risk of death and heart problems associated with the drug. But a larger study found no difference in heart risk when Uloric was compared to allopurinol. Uloric is said to work better for patients who have kidney problems too. Many gout patients also have kidney disease. While the FDA does not have to follow the recommendation of the committee, it typically does.
Related Resources:
- Gout Screening Quiz
- Test Your Knowledge: Gout
- Gout 101: Free Newsletter E-Course
- 10 Things You Should Know About Gout
- How to Recognize the Signs and Symptoms of Gout
Join the Discussion:
Photo © Image*After
When will Uloric be available for sale in the US?
Before making the final approval decision, the FDA will now review the new drug application (NDA) for Uloric/febuxostat. While the FDA does not have to follow the recommendation of the committee, it typically does. Here is a link to Takeda’s product pipeline at: http://www.takeda.com/pdf/usr/default/09_2_31536_4.pdf
My best,
Richard
What does “in license” mean? Is it currently being produced anywhere that a physician here in the States could prescribe it? Also, how long is the FDA review usually?
It is not yet available in the U.S. We will report as soon as we learn the FDA has approved it and will report a targeted marketing date when it’s announced. Regarding the term “in-license” I found this article that explains it somewhat as opposed to “in-house” research.
Uloric is now available in the US. My husband is the first patient to take it in our doctor’s office. It is not yet covered by insurance, however, the cost of it (through Blue Shield HMO of CA) is only $45 per month at the moment, which is not bad at all. He has been on it just coming up two weeks, and he has to go in to have his uric acid level checked to see if it is working. His last reading was 12.2 (he has acute gout), so cross your fingers! More later to see if it is working…
Good day very nice web site!! Man .. Beautiful .. Superb .. I will bookmark your blog and take the feeds also?I am satisfied to search out numerous useful information here within the submit, we’d like work out extra strategies in this regard, thank you for sharing. . . . . .