FDA Panel Recommends Approval For Takeda's Gout Drug
Japan-based Takeda is seeking FDA approval for Uloric to treat gout by lowering the amount of uric acid produced by the body. The FDA doesn't have to follow its panels' advice but generally does.
Panel members agreed the drug was effective at lowering patients' uric acid levels, but questioned whether Takeda presented enough information to rule our cardiovascular risks with the drug, a concern that has plagued the medicine in the past.
"The information we have is very limited," said panel member Curt Furberg, a doctor and professor at the Wake Forest University School of Medicine. He criticized the company's choice of patients it enrolled in clinical trials, saying the patients were at low risk for cardiovascular complications.
The FDA, however, didn't identify "a pattern suggesting an increased cardiovascular risk with" Uloric, said Jane Gilbert, a medical officer in the FDA division that reviews rheumatology products such as Uloric.
Twelve of 13 panel members voted to recommend approval, while one abstained from voting. The panel agreed the company needed to conduct rigorous post-marketing studies to better flesh-out potential cardiovascular risks associated with the drug.
Such a post-marketing study should be a combination of a large randomized trial and an observational study, said panel member Robert Harrington, a cardiologist at Duke University Medical Center. Harrington recommended approval for the drug.
Companies have long promised to conduct studies after FDA approves a drug, but don't always follow through. Some estimates show there are more than 1,000 outstanding post-marketing studies. Under powers Congress granted the FDA earlier this year, however, the agency can require companies to do such studies and impose penalties if they don't follow through.
Takeda has said it would conduct a post-marketing study, but the size and scope of any such study would have to be first discussed with the FDA.
Gout is characterized by acute pain, inflammation, redness, swelling, and heat in a person's joints. If approved Uloric would be the first FDA-approved therapy for gout in 40 years, said Nancy Joseph-Ridge, president of global research and development in North America for Takeda.
Takeda first submitted an application to the FDA on Dec. 14, 2004, seeking agency approval of the drug. The FDA later did not approve the drug because the agency said there was an "imbalance" in cardiovascular events seen in studies of patients receiving Uloric compared to patients receiving other drugs. The FDA has said Uloric is effective at treating gout.
Takeda submitted additional information to the FDA in 2006 to address the cardiovascular questions, but the agency still had questions about heart attack and stroke risks and asked Takeda to conduct a new clinical trial of Uloric that included a lower dose of the drug.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@dowjones.com
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(END) Dow Jones Newswires
November 24, 2008 16:12 ET (21:12 GMT)
Publié le 24 novembre 2008 Copyright © 2008 Dowjones
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