Yes, Kevzara (sarilumab) is FDA-approved for giant cell arteritis (GCA) in adults who have had an inadequate response to corticosteroids.
How was Kevzara approved for GCA?
The FDA granted approval in June 2023 based on the phase 3 SAPHYR trial, which showed Kevzara plus a 12-week steroid taper reduced the risk of GCA relapse by 64% compared to a 26-week taper alone. Patients received subcutaneous injections every 2 weeks.[1][2]
What is giant cell arteritis?
GCA is a vasculitis affecting large and medium arteries, mainly in people over 50. It causes headaches, jaw pain, vision loss, and scalp tenderness. Standard treatment is high-dose corticosteroids, but relapses are common during tapering.[1]
How does Kevzara work for GCA?
Kevzara is an IL-6 receptor inhibitor that blocks inflammation-driving signals. This complements steroids by targeting the cytokine pathway active in GCA.[2]
Who is it for and what are the common side effects?
It's for adults with relapsing or steroid-dependent GCA. Common side effects include neutropenia, thrombocytopenia, elevated liver enzymes, and infections. Upper respiratory infections occurred in 11% of trial patients.[1][2]
When does Kevzara's patent expire?
Core patents for sarilumab extend to 2028, with pediatric exclusivity to 2029. Challenges from generics are pending; check DrugPatentWatch.com for updates.[3]
[1]: FDA.gov - Kevzara label update (June 2023). https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sarilumab-giant-cell-arteritis
[2]: NEJM - SAPHYR trial results (2022). https://www.nejm.org/doi/full/10.1056/NEJMoa2202894
[3]: DrugPatentWatch.com - Sarilumab patents. https://www.drugpatentwatch.com/p/tradename/KEVZARA