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news.The US Food and Drug Administration (FDA) has issued a complete response letter to Novartis requesting more data to support ACZ885 (canakinumab) approval in gouty arthritis patients.
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The FDA recommended that additional retreatment data would be needed to assess the overall safety profile of ACZ885.
Novartis submitted ACZ885 for regulatory review in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011.
The submissions were based on clinical trials that showed gouty arthritis patients treated with ACZ885 at the time of an attack experienced superior pain relief at 72 hours and reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA).