Novartis Ilaris Approved For Extended Use In Periodic Fever
Zacks Investment Research | Sep 25, 2016 09:18PM ET
Switzerland-based Novartis AG (NYSE:NVS) announced that its arthritis drug, Ilaris, was approved in the U.S. for expanded use in the treatment of three distinct types of periodic fever syndromes – tumor necrosis factor-receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome/mevalonate kinase deficiency (HIDS/MKD) and familial Mediterranean fever (FMF).
The approvals were based on positive results from a pivotal phase III study, CLUSTER, which demonstrated rapid and sustained disease control through 16-weeks in patients with TRAPS, HIDS/MKD or FMF, in comparison to placebo.
In both the U.S. and the EU, Ilaris is already approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) and systemic juvenile idiopathic arthritis (SJIA). In the EU, Ilaris is approved for the treatment of patients with adult-onset still's disease (AOSD) and the symptomatic treatment of refractory acute gouty arthritis. The drug is currently approved in more than 70 countries.
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