Definitions
from Wiktionary, Creative Commons Attribution/Share-Alike License.
- noun A
human monoclonal antibody targeted atinterleukin -1 beta, intended to treatrheumatoid arthritis .
Etymologies
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Examples
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Ilaris, generically called canakinumab, attacks the underlying joint inflammation occurring in gout attacks.
FDA Panel Votes Against Gout Drug Thomas M. Burton 2011
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Results from a pivotal Phase III study, presented at this year's European Pediatric Rheumatology Congress in September, showed that ACZ885 (canakinumab) provided substantial symptom relief in patients with systemic juvenile idiopathic arthritis (SJIA).
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Ilaris canakinumab was approved as the treatment in Japan for cryopyrin-associated periodic syndrome, a rare and debilitating auto-inflammatory disease.
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First, a study of ACZ885 (canakinumab) showed it provided significant relief for patients with systemic juvenile idiopathic arthritis (SJIA).
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Ilaris canakinumab is approved in more than 50 countries, including the EU, US and Switzerland for the treatment of adults and children as young as four with CAPS.
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Agency issues Complete Response letter requesting more data to support approval; Novartis will continue to work with the FDA on next steps Novartis remains committed to studying ACZ885 in inflammatory diseases where interleukin-1 beta plays a key role Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for ACZ885 (canakinumab) in gouty arthritis patients.
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Gilenya (fingolimod), our breakthrough oral multiple sclerosis treatment, and Ilaris (canakinumab), for the treatment of cryopyrin-associated periodic syndrome (CAPS), both gained approval in Japan in the third quarter.
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Not all potential patients with these diseases would be eligible for treatment with canakinumab, if approved.
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"This study represents an important step forward for the rare disease community, as canakinumab treats the underlying causes of CAPS rather than just the symptoms," said Helen J. Lachmann, MD of the UK National Amyloidosis Centre at the Royal Free and University College Medical School in London, UK.
Presseportal 2009
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In part 1, 35 patients received 150 mg of canakinumab subcutaneously.
New England Journal of Medicine Lachmann, H. J., Kone-Paut, I., Kuemmerle-Deschner 2009
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