Sarilumab Approved for the Treatment of Adults with Glucocorticoid-Resistant PMR

First described in 1888, polymyalgia rheumatica (PMR) is a chronic inflammatory condition that almost exclusively affects individuals older than 50.¹ Until this week, no therapies for PMR had been approved by the U.S. Food & Drug Administration (FDA).² Tuesday, Sanofi announced sarilumab (Kevzara) has been approved by the U.S. Food & Drug Administration for the treatment of adults with PMR who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper.

The FDA approval for this new indication was based on results from the multicenter, phase 3 SAPHYR trial in patients with glucocorticoid-resistant, active PMR, which showed that almost three times as many patients treated with sarilumab achieved sustained remission than patients who received a placebo.³

References

1. Dasgupta B, Cimmino MA, Maradit-Kremers H, et al. 2012 Provisional classification criteria for polymyalgia rheumatica: A European League Against Rheumatism/American College of Rheumatology collaborative initiative. Ann Rheum Dis. 2012 Apr;71(4):484–492.
2. Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica. Regeneron. News release. https://investor.regeneron.com/news-releases/news-release-details/kevzarar-sarilumab-approved-fda-first-and-only-biologic. 2023 Feb 28.
3. Spiera R, Unizony S, Warrington K, et al. Sarilumab in patients with relapsing polymyalgia rheumatica: A phase 3, multicenter, randomized, double blind, placebo controlled trial (SAPHYR). Arthritis Rheumatol. 2022;74(suppl 9).