FDA requests additional clinical data on Novartis drug ACZ885 for the treatment of gouty arthritis

• Agency issues Complete Response letter requesting more data to support approval; Novartis will continue to work with the FDA on next steps

Basel, August 29, 2011 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for ACZ885 (canakinumab) in gouty arthritis patients. In its letter, the FDA requested additional information, including clinical data to evaluate the benefit risk profile in refractory patients.

On June 21, an advisory committee of the FDA voted in favor of the overall efficacy, but 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. These 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 a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA) .

ACZ885 was generally well tolerated in these studies, with most adverse events being mild to moderate in severity. Adverse events which included among others infections, were reported more frequently in patients treated with ACZ885 vs. those treated with TA.