Biotech Values

[jbog]

A U.S. advisory panel on Tuesday rejected a Novartis AG 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 Ilaris for treating gout attacks. The panel also voted 12-0 against Ilaris for delaying and reducing the frequency of future attacks.

Most advisers said the drug was effective in company studies of gout patients. But it also was linked to higher rates of serious infections and other potential side effects that raised concern.

Ilaris already is sold for treating a rare inflammatory disorder. Novartis has predicted the drug could generate blockbuster sales if it won clearance for gout and juvenile rheumatoid arthritis.

The panel's rejection makes U.S. approval for gout unlikely without more data because the FDA usually follows panel recommendations.

Gout is a type of arthritis that occurs when uric acid builds up in the joints. Typically one or a few joints are affected such as the big toe or ankle.

((Ilaris is approved to treat CAPS in the states, but it an extremely small population (300))