Sanofi — Kevzara EMA EPAR public assessment report (EMEA/H/C/004254, 2017)
Sanofi · 2017 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's 2017 assessment led to the marketing authorization of Sanofi's Kevzara (sarilumab) for moderately to severely active rheumatoid arthritis in adults inadequately responsive to DMARDs or TNF antagonists, for use with methotrexate or as monotherapy. The report details sarilumab's manufacturing, non-clinical pharmacology (IL-6Rα inhibition), and pharmacokinetic/pharmacodynamic properties, noting dose-dependent efficacy and safety. Clinical trials consistently demonstrated sarilumab's superiority over placebo and adalimumab in improving disease activity (ACR20/50/70, DAS28-CRP), physical function (HAQ-DI), and inhibiting structural damage (mTSS). Safety concerns include infections, neutropenia, elevated liver enzymes, and gastrointestinal perforations, necessitating a robust risk management plan. Long-term safety data for malignancies and cardiovascular events remain limited.
Key findings — cited to the page
| Incidence of grade 3 or 4 neutropenia (%) | 7.7 % | MSC12665 · p.36 |
| Incidence of grade 3 or 4 neutropenia (%) | 7.1 % | MSC12665 · p.36 |
| mTSS (Median) | 1.00 | EFC11072 part B · p.123 |
| CDAI | -26.08 | EFC10832 - SARIL-RA-TARGET · p.128 |
| HAQ-DI (LS mean) | -0.46 | EFC10832 - SARIL-RA-TARGET · p.127 |
| ACR20 response | 58.0% % | EFC11072 part B · p.123 |
| HAQ-DI (LSmean) | -0.55 | EFC11072 part B · p.123 |
| ACR20 response | 66.4% % | EFC11072 part B · p.123 |
| Procedure start date | 14 July 2016 | · p.7 |
| Positive opinion for marketing authorization date | 21 April 2017 | Kevzara · p.7 |
| Approved indication | Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. | Kevzara · p.10 |
| mTSS (Median) | 0.00 | EFC11072 part B · p.123 |
Source: Sanofi ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →