Ilaris Not Able to Pass FDA Review

LLaris proposed to treat gout declined by the FDA

(RxWiki News) The biologic drug canakinumab (Ilaris) does work in treating acute flares of gout but is found to be too risky to warrant Federal Drug Administration (FDA) approval.

The 12-member panel unanimously decided that Ilaris did not pass the safety test well enough to warrent approval by the FDA, especially considering that Ilaris only treats the symptoms of gout, not the underlying disease.

Ilaris denied approval for the treatment of acute gout symptoms.

FDA officials asked this question regarding justification of drug approval: "Given that (Ilaris) is expected to provide primarily a symptomatic benefit, is the risk of infection still outweighed by the clinical benefits?" The answer is a resounding no.

Members of the panel did agree by almost as large a margin, an 11-1 vote, that the efficacy data adequately showed that there was real symptomatic relief.

When addressing the question regarding whether Ilaris reduced frequency of future attacks, the panel was much more divided. The panel voted 8-4 in favor of finding evidence to support this claim.

Thumbs down decidedly was the panels vote when asked whether the effectiveness of the drug compared to the risks associated with that drug justified approve: 11-1. Also thumbs down to recommending Ilaris to prevent future attacks considering its risks: 12-0.

FDA staff also raised their concerns regarding increased rates of infections, elevated uric acid levels in blood and high triglyceride levels seen in the drug's clinical trials for gout and rheumatoid arthritis.

Ilaris is already approved for two rare inflammatory diseases, familial cold autoinflammatory syndrome and cryopyrin-associated period syndromes, which is known as Muckle-Wells syndrome.

In several studies reported at recent meetings, the drug was found to reduce pain associated with acute gout attacks and lessen the frequency of attacks by about 60% to 70% in patients with a history around once every other month flare ups a year. Serious infections were seen in almost 2 percent of the 691 patients treated with Ilaris in the trials, whereas none occurred in about 400 control patients receiving triamcinolone or colchicine.

40 percent of patients who received the 150-mg dose of Ilaris had increases in their triglycerides above the normal range. 10% of the patients receiving the 150-mg dose of ilaris had triglyceride levels 2.5 times the upper limit of normal or more.

Increases in serum uric acid were also observed, affecting 36 percent of patients in one trial and 27 percent in another. Both these studies exceeded the percentage increase in the control group.

Review Date: 
June 21, 2011