Sept 16 (Reuters) - Patients with the most serious form of childhood arthritis can get substantial symptom relief from a Novartis drug, researchers said on Friday, raising hopes for a product that had a recent setback in its application to treat gout.
Ilaris, or ACZ885, blocks a protein called interleukin-1 beta linked to inflammation. It is already sold for treating cryopyrin-associated periodic syndromes, a rare inflammatory disorder, but U.S. regulators decided last month they were not ready to approve it for gouty arthritis[#msg-66616782].
The drug's success in systemic juvenile idiopathic arthritis (SJIA) is therefore a significant boost to confidence in its future.
Results of the first of two final-stage Phase III trials of ACZ885 in SJIA found 83.7 percent of patients experienced at least a 30 percent improvement in symptoms against 9.8 percent for those on a placebo, and 32.6 percent of ACZ885 patients had a 100 percent improvement.
The findings were presented at the European Pediatric Rheumatology Congress in Bruges, Belgium. John Hohneker, head of development for integrated hospital care at Novartis, told Reuters the data was "outstanding".
Pierre Quartier of the Necker-Enfants Malades Hospital, Paris, who was one of the investigators on the study, said it suggested ACZ885 could become an important treatment option for children with SJIA.
Novartis plans to file for regulatory approval of the drug in SJIA in 2012 in both the United States and Europe, based on data from this and a second Phase III trial, which will be presented later this year.[The second phase-3 trial is nominally still in progress, but NVS presumably knows the outcome already.]
Novartis is banking on new products to help it offset patent losses on big sellers such as blood pressure treatment Diovan. Expectations for Ilaris, however, are relatively modest in the wake of the disappointment over its potential use for gout. Analysts, on average, forecast sales of $412 million in 2016, according to Thomson Reuters Pharma.
Researchers said the SJIA study did not uncover any new safety findings and no patients had to discontinue treatment due to adverse events. The study met all its primary and secondary endpoints.
SJIA affects less than one child per 100,000. It causes inflammation affecting the whole body, which can involve skin rash, fever, joint pain and swelling.‹
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