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18-06-2020 | Rheumatology | News | Article

approvalsWatch

FDA approves canakinumab for adult-onset Still’s disease

medwireNews: The US FDA has expanded the indication for the interleukin (IL)-1 inhibitor canakinumab to include adult-onset Still’s disease (AOSD).

“Prior to today’s approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers and rash,” said the FDA’s Nikolay Nikolov in a press release.

Canakinumab was previously approved for systemic juvenile idiopathic arthritis (sJIA), and the FDA notes “considerable overlap” between sJIA and AOSD, with IL-1 having an important role in the pathophysiology of both conditions.

The approval of canakinumab was based on extrapolation of the established efficacy of the IL-1 inhibitor in sJIA, as well as studies demonstrating its safety in AOSD and other conditions, and the drug was granted a Priority Review designation.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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