FDA approves Ilaris for the treatment of gout flares in adults
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The FDA has approved Ilaris for the treatment of gout flares in adults, marking it as the first biologic therapy to receive the nod for this indication, according to a statement from Novartis.
“At Novartis, we are committed to bringing medicines that address high unmet needs to patients,” a company spokesperson told Healio in an email. “We are proud to receive approval on our eighth indication for Ilaris in the United States and provide the first biologic medicine option for people with gout flares to help treat this painful and debilitating condition.”
According to the FDA, this expanded indication for Ilaris (canakinumab, Novartis) is intended for patients for whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, as well as those who are not appropriate candidates for repeated courses of corticosteroids.
The approval is rooted in phase 3 clinical trials that demonstrated the drug “significantly reduced pain intensity at the most affected joint, and showed a reduction in time to a new flare,” compared to the injectable steroid triamcinolone acetonide, the Novartis statement read.
The study additionally unearthed no unexpected safety findings, the statement added. The most common adverse events were a common cold, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia and back pain.
The approval also follows a prior rejection. In 2011, an FDA advisory panel voted 11-1 against recommending approval for canakinumab, an anti-interleukin-1 monoclonal antibody, for gout flares citing concerns regarding potential side effects, including serious infections. Members of the panel also noted a lack of long-term data at the time.
Canakinumab had previously been approved for the treatment of active Still’s disease, including adult-onset Still’s Disease, systemic juvenile idiopathic arthritis in patients aged 2 years and older, and periodic fever syndromes.
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Novartis statement
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