Canakinumab(ACZ885), human monoclonal antibody finds rejection as the advisors of the US Food and Drug Administration donot approve it for the treatment of gout.The Novartis drug Canakinumab got approval for the treatment of (CAPS-Cryopyrin periodic syndromes) by US FDA(June 2009) and by EMA(October 2009).Canakinumab(Ilaris) is a recombinant Interleukin-1 beta inhibitor.
Frequent recurrence prevails
5% of all cases of arthritis are caused by gout. Gout(also known as Podagra) is a condition that occurs when needle shaped crystals of uric acid is accumulated in the joints,tendons and tissues.High levels of uric acid level in blood results in the accumulation. Gout can affect parts of the body like heels ,insteps (arches of your feet),ankles ,finers,knees,elbows,wrists.Its very painful and results in inflammatory arthritis.US FDA Arthritis Committee rejected Novartis drug Ilaris(Canakinumab), as it failed to meet the expected treatment and safety standards.The drug failed to provide necessary relief to patients who couldnot benefit from anti inflammatory drug ACZ885(Canakinumab) and cannot reduce the future attack risks and frequencies.
Couldnot meet safety standards
Ilaris could not meet the safety concerns of the advisory panel against arthritis.Members claimed the failure of Canakinumab to treat large population of gout patients.As per the study it was concluded that Ilaris intake may lead to other serious and harmful life threatening side effects.High level of lipid in blood and high risks of kidney disease and kidney failure were quoted.Novartis still claims the potential benefits of Canakinumab in treating the painful disease gout and is now concentrating to find the particular group of gout patients who can benefit from this drug.
Arthritis advisory committee’s recomendation will be considered by FDA, while reviewing the sBLA application for Canakinumab submitted by Novartis to FDA. ACZ885 (Ilaris) will be reviewed based on the PRV (priority review voucher) and a decision would be taken by the third quarter of 2011. Based on the results of phase III clinical trials conducted by Novartis, which showed positive response of the drug towards gouty arthritis the recommendation was made.The clinical trial proves Ilaris better compared to triamcinolone acetnide (injectible steroid).
Ilaris does not improve the root cause
3.9 % population of people in US suffers from this severe painful gouty arthritis.Many drugs like colchicine and other injectable steroids are available for the treatment of gout but people with other medical ailments cannot rely on these drugs.FDA clinical researcher concluded the FDA panel discussion by stating Novartis, drug Ilaris doesnot improve the root cause of the gout, it just works on the symptom.