The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.
In an ACR Convergence 2022 session, Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery, New York City, discussed the use of sarilumab as a potential glucocorticoid-sparing therapy in a phase 3 study in patients with treatment-refractory polymyalgia rheumatica (PMR), one of the most common inflammatory diseases…
On Feb. 28, 2023, the U.S. Food & Drug Administration (FDA) approved sarilumab (Kevzara) for the treatment of adults with polymyalgia rheumatica (PMR) for whom glucocorticoids have proved inadequate or who cannot tolerate a glucocorticoid taper.1,2 Sarilumab is an interleukin (IL) 6 receptor antagonist. In May 2017, the FDA initially approved the agent for the…
Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.
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…
(Reuters)—On April 27, Regeneron Pharmaceuticals Inc. and Sanofi SA said on Monday that their arthritis drug sarilumab (Kevzara) may only help the sickest patients with COVID-19, dampening hopes that the therapy could potentially reach a larger pool of patients with the disease. The drugmakers said they would test high doses of sarilumab only in critically…
A study investigating sarilumab’s effects on patients with COVID-19 has begun in New York. The treatment blocks IL-6, which may play a role in the respiratory distress caused by the virus…
Recent post-hoc analyses of two Phase 3 clinical trials show that RA patients with high interleukin 6 levels taking sarilumab experienced improved symptoms and less joint damage than those using other treatments…
In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…