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Novartis wins childhood arthritis indication for Ilaris in EU

EC gives green light to drug for the treatment of systemic juvenile idiopathic arthritis

Novartis building

Novartis' inflammatory disease drug Ilaris (canakinumab) can be used more widely in the EU following its approval for the treatment of a rare form of childhood arthritis.

The European Commission (EC) gave its final assent to Ilaris for the treatment of systemic juvenile idiopathic arthritis (SJIA), which can lead to spiking fever, rash and arthritis and can affect children as young as two.

Ilaris gains a new indication as a monthly subcutaneous injection in patients aged two years and older who have not responded to therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.

The approval adds to Ilaris' existing approvals in the EU to treat the rare inflammatory disorder cryopyrin-associated periodic syndromes (CAPS), which can lead to deafness and loss of vision, and gouty arthritis, which is a painful inflammation of the joints.

Thought to be affect about 0.4 to 0.8 per 100,000 people in the UK SJIA is another rare disease, an area of increasing attention for larger pharma companies given the incentives regulators provide to orphan drugs and the market need to create better targeted medicines.

“[The approval] represents another significant milestone in the development of Ilaris as a novel therapy for patients with rare, inflammatory diseases, where interleukin-1 beta plays a key role,” said Dr Timothy Wright, global head of development at Novartis.

There are few treatment options available for SJIA and Ilaris demonstrated its effectiveness in clinical trials, including one where 84 per cent of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of improvement shown by measures using the American College of Rheumatology (ACR) Paediatric 30 criteria. This compared to just 10 per cent of patients on placebo.

The drug is also recommended in the US where it won approval from the Food and Drug Administration (FDA) in May 2013.

Novartis is hoping to expand the use of canakinumab even further, and two phase II trials are ongoing investigating its use in two diseases characterised by periodic fevers: familial Mediterranean fever (FMF) and tumour necrosis factor receptor-associated periodic syndrome (TRAPS). Both conditions are also classified as rare diseases.

4th September 2013

From: Sales

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