FDA advisory panel does not support approval of Ilaris for gouty arthritis
An advisory committee of the FDA voted 11-1 against the approval of Novartis Pharmaceuticals supplemental biologics license application 125319 for the treatment of gouty arthritis attacks because of safety concerns.
The committee voted in favor of the overall efficacy, but not the overall safety of Ilaris (canakinumab, Novartis Pharmaceuticals) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with NSAIDs or colchicine. Committee members raised the potential for use in a more narrow population of patients with gouty arthritis. Ilaris is a fully human monoclonal antibody that targets interleukin-1 beta.
We continue to believe in the benefits of ACZ885 [Ilaris] 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, Trevor Mundel, MD, global head of development at Novartis Pharmaceuticals, stated in a company press release. We are encouraged by the committees enthusiasm and robust discussion, and remain committed to addressing the needs of people with gouty arthritis.
The committees recommendation will be considered by the FDA in its review of the supplemental biologics license application that Novartis submitted for Ilaris. The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug approval, although it is not obliged to follow the recommendations.
The committee reviewed results of two pivotal phase 3 studies in which the efficacy of Ilaris 150 mg during 24 weeks was studied in more than 450 patients with gouty arthritis. Both trials measured differences in pain 72 hours after treatment. Patients treated with Ilaris had a significantly lower mean pain score from baseline compared with triamcinolone acetonide (TA) 40 mg. Patients receiving Ilaris also experienced a significant reduction in the relative risk of suffering a new gouty arthritis attack within 24 weeks, by 56%, compared with patients receiving triamcinolone acetonide.
Twenty-eight percent of patients treated with Ilaris experienced new attacks during a 24-week period compared to 49% treated with triamcinolone acetonide. Across both studies, 69.6% of patients had adverse events with Ilaris vs. 57% with TA. Serious events were reported by 18 patients treated with Ilaris vs. nine patients on TA.
Ilaris was approved in the United States in June 2009 for the chronic treatment of rare genetic disorders known as cryopyrin-associated periodic syndromes (CAPS) in adults and children 4 years of age and older. It is currently available in sterile, single-use, 6-mL glass vials containing 180 mg of canakinumab as a lyophilized powder for reconstitution. The approved dose in adult CAPS patients is 150 mg subcutaneously every 8 weeks.