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Novartis gets FDA green light for new Ilaris indication

Immunotherapeutic wins US approval for severe form of childhood arthritis

Novartis buildingThe US FDA has cleared another indication for Novartis' fast-growing immunotherapeutic Ilaris, this time giving the nod to its use in a severe form of childhood arthritis.

Ilaris (canakinumab) - which acts as an inhibitor for the cytokine interleukin-1 beta - is now approved as a treatment for active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older, adding to its current use in the rare genetic disorder cryopyrin-associated periodic syndromes (CAPS).

SJIA is the most aggressive form of juvenile arthritis and afflicts 5-15 children out of 100,000, according to Novartis, which added that current treatment relies heavily on corticosteroids which can have serious side effects.

In trials, 84 per cent of Ilaris-treated SJIA patients achieved a 30 per cent improvement in symptoms 15 days after being given a single subcutaneous dose of the drug. Only 10 per cent of a matched group treated with placebo saw the same improvement. 

Meanwhile, in an open-label extension phase in which Ilaris was given once a month, two thirds of patients were able to substantially reduce corticosteroid use, and 46 per cent stopped using them altogether.

Ilaris was first launched in the US and EU in 2009 as a treatment for CAPS, and since then Novartis has also won approval in Europe for its use in gouty arthritis. Efforts to get a gouty arthritis indication in the US were knocked back in 2011, however, when the FDA - which has adopted a cautious stance on new gout therapies - asked for more data in its risk-benefit profile.

The new SJIA indication will add further momentum to Ilaris, which grew 56 per cent last year to reach $72m in sales. Novartis is also planning to seek approval in other IL-1 beta mediated inflammatory diseases, including "several rare diseases for which treatment options do not currently exist", according to the firm's global head of development Timothy Wright.

Other uses being assessed include tumour necrosis factor receptor-associated periodic syndrome (TRAPS), colchicine-resistant familial Mediterranean fever (FMF) and hyper IgD syndrome (HIDS), and analysts have suggested that - collectively - the indications could drive Ilaris revenues towards the $1bn mark at peak.

10th May 2013

From: Sales

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