FDA rejects Novartis’ Ilaris for gouty arthritis
pharmafile | June 22, 2011 | News story | Research and Development |Â Â Ilaris, Novartis, gouty arthritisÂ
An FDA advisory panel has voted against backing Novartis’ Ilaris for gouty arthritis because of safety concerns.
Ilaris (canakinumab) is already licenced to treat the auto-inflammatory disease cryopyrin-associated periodic syndrome, but Novartis is hoping to extend its licence so the drug can be used to treat gouty arthritis after patient fail on drugs like ibuprofen or colchicine.
But the advisors’ 11-1 vote against an extension is a blow to Novartis as the FDA usually follows the advice of its panel.
Their main concern was the safety of the drug, as trials showed that patients receiving just one injection were at a higher risk of serious infections.
But it did find that Ilaris – or ACZ885 – was effective against gouty arthritis, a chronic auto-inflammatory disease characterised by recurrent attacks in the joints.
In recent phase III studies in 450 patients with gout, Ilaris was shown to reduce pain levels and the risk of a new flare-up by 55% in one study and 68% in another, compared with a standard steroid injection.
This led several panel members to say they hoped Novartis could present more data in order to get the drug to market in the future.
Trevor Mundel, global head of development at Novartis, said: “We continue to believe in the benefits of ACZ885 for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy.
“We are encouraged by the committee’s enthusiasm and robust discussion and remain committed to addressing the needs of people with gouty arthritis.”
Ilaris made only modest sales of $26 million last year, despite being on the market since 2009, but Novartis believes that adding gout and juvenile rheumatoid arthritis to its licence could push the drug’s annual sales into the blockbuster realm of more than $1 billion.
Ilaris, a fully human monoclonal antibody that neutralises interleukin-1 beta (IL-1 beta), would represent the first new class of therapies in nearly 50 years to treat the pain and inflammation of gouty arthritis.
Currently there are no targeted biologics for gouty arthritis except for non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine.
Novartis has also filed the drug with the EMA with a decision on its application for gouty arthritis patients with limited treatment options expected later this year.
Ben Adams
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