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FDA Panel Recommends Approval of New Gout Drug

Posted Dec 20 2008 7:14pm

I posted last month about a new gout drug being tested by Takeda Pharmaceutical. Based on the results of that testing a U.S. Food and Drug Administration (FDA) expert panel has recommended that febuxostat be approved. This would make febuxostat, to be marketed as Uloric, the first gout drug to be approved in over 40 years.

Until now, the only drug approved for treatment of gout was allopurinol, marketed under the name Zyloprim. Allopurinol prevents the formation of uric crystals that cause gout. However, allopurinol has some potentially fatal side effects which limits the amount that can be taken by gout patients.

Takeda had submitted Uloric to the FDA in 2005, but it was denied due to reports of more heart problems in patients taking it than in allopurinol. The recent tests were a response to those concerns, which found that there is no more risk for patients taking Uloric than those taking allopurinol. In addition, very little Uloric is eliminated in the urine which makes it safe for patients with kidney problems.

The trials showes that an 80mg dose of Uloric worked better than allopurinol and a 40mg dose worked just as well.

Takeda has offered to continue studies of Uloric after receiving FDA approval. Specifically, they will conduct a phase 4 clinical trial to compare Uloric to allopurinol for treatment of gout flare-ups.

The FDA panel has recommended that the FDA approve Uloric by a 12-0 vote. The FDA usually takes the advice of its panelists and will weigh the recommendation before making its final decision, which is expected to come by Jan. 16.


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