Thursday, February 28, 2013

Novartis receives EU approval for Ilaris in patients suffering acute gouty arthritis attacks who cannot gain relief from current treatments

Novartis announced today that the European Commission (EC) has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered in a single, subcutaneous injection of 150 mg

Ilaris is specifically indicated for the 'symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate

About Ilaris Phase III Studies
Ilaris has been assessed for the treatment of acute gouty arthritis attacks in two multi-centre, randomized, double-blind, active-controlled studies in patients with frequent gouty arthritis attacks (>=3 in the previous year) who were unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy). The studies were 12 weeks in duration followed by 12 week double-blind initial extensions.
A total of 454 patients were randomized to receive a single dose of Ilaris 150 mg via subcutaneous injection or TA 40 mg via intramuscular injection. Both trials used an internationally recognized pain scale (visual analogue scale, or VAS) to measure differences in pain 72 hours after treatment. Pain intensity in the overall study population was statistically significantly lower for Ilaris 150 mg compared to TA at 72 hours (-10.7 mm, p<0 -50="" .0001="" absolute="" an="" approximately="" as="" decrease="" early="" in="" mean="" mm.="" nbsp="" observed="" of="" pain="" reduction="" score="" span="" vas="" was="" with="">6 hours after dosing in both groups. A statistically significant difference between treatments was observed from 24 hours to 7 days. Ilaris also reduced the risk of subsequent attacks
Safety results showed an increased incidence of AEs for Ilaris compared to TA, with 66% vs. 53% of patients reporting any adverse event and 20% vs. 10% of patients reporting an infection adverse event over 24 weeks
A sub-analysis of these studies included 101 patients unable to use NSAIDs and colchicine, and on stable urate lowering therapy (ULT) or unable to use ULT. Pain relief was similar to that shown in the total study population (-10.2 mm for Ilaris 150 mg compared with TA at 72 hours, p=0.0208).

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