|FDA panel rejects Novartis drug|
|By Staff and Wire Reports|
|Tuesday, 21 June 2011 20:34|
The FDA voted 11-1 rejecting Ilarisa, the proposed trade name, a Novartis AG (NYSE:NVS) drug for gout over concerns about side effects, a setback for the company's efforts to expand use of the medicine.
A committee of Food and Drug Administration advisers voted 11-1 against recommending approval of the drug for treating attacks of gout, a common form of inflammatory arthritis that affects about 8.3 million U.S. adults.
The panel also unanimously voted against the drug for delaying and reducing the frequency of future attacks.
Most advisers said the drug was effective in company studies but it was also linked to higher rates of serious infections and other potential side effects.
Advisers also focused on the lack of long-term data. In a company study, out of 454 patients only 43 had three or more injections of Ilaris, making it difficult to measure the effects of the drug over time.
Ilaris, which blocks a protein that is thought to increase inflammation, is already sold for treating a rare inflammatory disorder. Novartis had predicted the drug could generate blockbuster sales if it won clearance for gout and juvenile rheumatoid arthritis.
The FDA usually follows panel recommendations. The agency is due to make a decision on the drug by year-end, Novartis said.
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