Kevzara sarilumab APPROVED
Drug Profile
ModalityMonoclonal antibody
RouteSC
Therapy AreaImmunology
Launch2017-05-22
Peak Sales Est$1000M
Formulations[{"id":"kevzara-sc","doses":"150mg or 200mg Q2W","route":"SC","device":"Pre-filled syringe or pre-fi
Companies
REGN (CO_DEVELOPER)50%
SNY (CO_DEVELOPER)50%
Mechanism: Anti-IL-6R (Recycling)
Expert: Anti-IL-6 receptor antibody with recycling technology for extended half-life, blocking IL-6 signaling in autoimmune conditions.
Everyday: An antibody that blocks an inflammation signal and is engineered to stay active in the body longer than older versions.
Targets: ["IL-6R"]
Revenue History
PeriodRevenue ($M)
Q1 2024$94M
Q2 2024$110M
Q3 2024$120M
Q4 2024$135M
2024$459M
Q1 2025$116M
Q2 2025$152M
Q3 2025$154M
Q4 2025$152M
2025$575M
Programs (1)
IndicationStageKey StudyRegional Status
RA (TNF-IR)APPROVEDSARIL-RA-MOBILITY / TARGET[{"stage":"APPROVED","region":"US","approval_date":"2017-05-22"},{"stage":"APPRO
Clinical Studies (1)
SARIL-RA-MOBILITY PHASE3
COMPLETED · n=1197
Primary EP: [{"id":"mobility-acr20","name":"ACR20 at Week 24","type":"CO_PRIMARY","unit":"%","results":[{"value":66,"arm_id":"sarilumab-200-mobility","p_value":"<0.0001","arm_name":"Sarilumab 200mg"},{"value":33,
Efficacy: Met all 3 co-primary endpoints: ACR20 66% vs 33% (p<0.0001), HAQ-DI improvement (p<0.0001), 91% less radiographic progression (mTSS 0.25 vs 2.78, p<0.0001).
Safety: MOBILITY (n=1197, 52 weeks): Infections 40% vs 32%, neutropenia 6.4% vs 0.8%, ALT>3xULN 4.3% vs 1.5%. IL-6R class effects.
NCT01061736
Notes
50/50 co-development with Sanofi. IL-6R antagonist (same class as Actemra/tocilizumab from Roche). Approved for moderate-to-severe RA after TNF-IR. Smaller franchise but stable contributor.
Safety Profile
{"keyRisks":[{"category":"Serious infections","description":"Bacterial pneumonia, UTI, cellulitis, herpes zoster, diverticulitis. Do not start if active infection present. Screen for TB.","incidenceRate":"3.4% vs 2.5% placebo per 100 patient-years"},{"category":"Neutropenia","description":"IL-6 receptor blockade causes dose-dependent neutrophil decrease. ANC <1000: 6.4% (200mg) vs 0.8% placebo.","incidenceRate":"6.4% Grade 3-4"},{"category":"Elevated liver enzymes","description":"ALT elevation >3x ULN in 4.3% (200mg). Monitor LFTs.","incidenceRate":"4.3%"},{"category":"Lipid elevations","description":"IL-6R blockade increases LDL, TG. Check lipids 4-8 weeks after initiation.","incidenceRate":"Expected pharmacological effect"},{"category":"GI perforation","description":"Primarily in patients with diverticulitis. Risk with IL-6R inhibition.","incidenceRate":"0.1%"},{"category":"Injection site reactions","description":"Erythema, pruritus at injection site.","incidenceRate":"9.5%"}],"monitoring":["Neutrophil count before each dose (hold if ANC <1000)","LFTs Q4-8W for first 6 months","Lipids at 4-8 weeks post-initiation","TB screening before starting"],"classWarnings":["IL-6R inhibitor: serious infection risk, neutropenia, hepatotoxicity, GI perforation","Same class as tocilizumab (Actemra)"],"hasBoxedWarning":true,"boxedWarningText":"SERIOUS INFECTIONS: Serious infections leading to hospitalization or death including tuberculosis, bacterial, invasive fungal, viral, and other opportunistic infections. If a serious infection develops, interrupt Kevzara. Test for latent TB before starting."}
Data from Supabase · Updated 2026-03-24