Kevzara(sarilumab)
Immunology· 4572 cited findings· 3 source documents
Company: Sanofi →
What the regulatory reviews say
Kevzara (sarilumab) is a drug indicated for the treatment of rheumatoid arthritis. Efficacy results from clinical trials show varying ACR20 response rates, including 56%, 61%, and 34% in different arms, and 46.2%, 49.0%, 66.7%, 62.0%, 65.4%, and 72.0% in other assessments. ACR50 response rates ranged from 15.4% to 40.4%. The least squares mean change in HAQ-DI was -0.53. The primary endpoint for efficacy was ACR20, and for physical function, it was HAQ-DI.
Safety data indicates that the percentage of patients experiencing any treatment-emergent adverse event (TEAE) ranged from 43.1% to 72.0%. The percentage of patients with any serious adverse event (SAE) ranged from 3.9% to 6.0%. TEAEs leading to death were reported in 2.0% of patients.
The marketing authorization application for Kevzara was submitted on June 24, 2016, and the date of submission for the FDA review was October 30, 2015. Sanofi acquired sarilumab in 2009. Clinical trials had a study duration of 52 weeks and involved 6 arms.
Key figures — cited to the source page
| ACR20 response rate | 56% | Sanofi — Kevzara FDA Review, p.220 |
| ACR20 response rate | 61% | Sanofi — Kevzara FDA Review, p.220 |
| ACR20 response rate | 34% | Sanofi — Kevzara FDA Review, p.220 |
| LS Mean Change in HAQ-DI | -0.53 | Sanofi — Kevzara FDA Review, p.221 |
| Patients with any TEAE (%) | 72.0 | Sanofi — Kevzara FDA Review, p.106 |
| Patients with any SAE (%) | 6.0 | Sanofi — Kevzara FDA Review, p.106 |
| Patients with any TEAE leading to death (%) | 2.0 | Sanofi — Kevzara FDA Review, p.106 |
| Date of Submission | October 30, 2015 | Sanofi — Kevzara FDA Review, p.514 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.