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June 21, 2011

Proposed Gout Drug Should Not Be Approved, Public Citizen Tells FDA

Risks Outweigh Benefits in Drug to Treat Gouty Arthritis Attacks

WASHINGTON, D.C. – A drug proposed to treat patients with gouty arthritis attacks should not be approved because it has serious, life-threatening risks that far outweigh the drug’s clinical benefits, Public Citizen said today in testimony before the Food and Drug Administration’s (FDA) Arthritis Advisory Committee.

The drug, canakinumab, also known as Ilaris, is a potent immunosuppressant agent that currently is approved by the FDA only for a rare serious genetic disorder called cryopyrin-associated periodic syndrome (CAPS), which causes widespread inflammation in the body. For gout, this drug would provide limited benefits, primarily relief of pain from acute gout flares, Public Citizen said.

“The FDA said that whether to approve the drug was ‘complicated,’ but it is not complicated at all,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Canakinumab is a potent and dangerous drug. While the risks of this drug are justified for patients with CAPS, a life-threatening disease, these risks are not outweighed by the symptomatic benefit provided in patients with gout. Therefore, in the interests of protecting the public health, the FDA should not approve canakinumab for the treatment of gout.”

In its review of the results of data from clinical trials testing canakinumab in gout patients, the FDA identified some significant safety concerns about the drug.

In the clinical trials, gout patients taking canakinumab suffered from serious adverse reactions more than twice as often and had more serious infections than those patients treated with triamcinolone, a standard drug approved by the FDA for gout. Patients taking the former also were more likely to experience low white blood cells counts, which can lead to infection; decreased levels of platelets, which play a key role in stopping bleeding; a reduction in kidney function; elevated levels of serum triglycerides and serum uric acid; and liver dysfunction.

“The increased rate of the serious infections in gout patients after just a single injection of canakinumab is a unique and concerning observation in this development program,” the FDA noted in its briefing document for the Arthritis Advisory Committee meeting today that was posted on the FDA website on June 17.

Novartis, the drug’s manufacturer, estimates that approximately 300,000 gout patients will be candidates for canakinumab if it is approved for this condition. However, it is highly likely that off-label use will result in many more gout patients being treated with this drug, Carome said.

Even with approved use for acute gout attacks in a patient population of 300,000, repeated dosing with canakinumab will result in large numbers of serious infections and other life-threatening complications, Carome said. The drug should not be approved, he said. 

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