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Novartis buoyed by pivotal data on arthritis drug

Trial results will support canakinumab's application for a systemic juvenile idiopathic arthritis licence

Patients with a childhood form of arthritis can dramatically reduce their reliance on oral steroids when treated with Novartis' canakinumab, according to the results of a second phase III trial in this indication which are due to be presented later this week.

The positive results put Novartis on track to file for approval of canakinumab in systemic juvenile idiopathic arthritis (SJIA) next year, potentially transforming the commercial prospects for the interleukin-1 beta inhibitor.

The phase III trial - which will be presented at the American College of Rheumatology annual meeting tomorrow - shows that 45 per cent of children with active SJIA who were treated with canakinumab were able to substantially reduce their use of oral steroids. Chronic steroid use is a major problem in childhood arthritis as it is linked to a number of complications, including slowed growth and delayed puberty.

Meanwhile, SJIA patients treated with canakinumab were nearly three times less likely to suffer a worsening of symptoms known as a flare compared to those receiving placebo. Only 27 per cent of ACZ885-treated patients experienced a new flare over the course of the study versus 75 per cent of patients on placebo.

"Steroids help manage many SJIA symptoms, such as fever and inflammation, but doctors try to minimise their use because of the potential negative impact on bones and growth," commented Daniel Lovell of the Cincinnati Children's Hospital Medical Center in the US, one of the study investigators.

Despite only affecting 1 in 100,000 children, SJIA is considered to be an important new indication for canakinumab, which was launched onto the US and EU markets under the brand name Ilaris in 2009 for an auto-inflammatory disease called cryopyrin-associated periodic syndrome, but brought in just $26m in sales last year.

Novartis has a strategy of positioning new drugs in niche indications and then gradually broadening out their use, and it has predicted that adding juvenile arthritis to the label could push it towards blockbuster status.

That strategy took a knock in August, however, after the US Food and Drug Administration (FDA) decided not to approve canakinumab for gouty arthritis on the grounds that Novartis needed to provide more data on the drug's risk-benefit profile, specifically its potential to leave patients vulnerable to infections.

Analysts had predicted that approval in gout and juvenile arthritis along with CAPS could push sales of the drug above $1bn a year.

8th November 2011

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