Sanofi — Kevzara EMA EPAR variation assessment report (EMEA/H/C/004254, 2017)
Sanofi · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This EMA report assesses Sanofi's variation application for Kevzara (sarilumab) to include a new 175 mg/mL vial and extend its indication to active polyarticular-course juvenile idiopathic arthritis (pcJIA) in patients aged 2 and older. Supported by study DRI13925, the application details sarilumab's pharmacokinetic, pharmacodynamic, and immunogenicity profiles in pcJIA, comparing them to adult rheumatoid arthritis patients. Efficacy data from the open-label study showed high JIA ACR response rates maintained up to 3 years. Safety analysis revealed common adverse events like infections and neutropenia, consistent with the adult profile, with no new concerns identified. The proposed dosing aims for similar sarilumab exposure as in adult RA, and the extrapolation concept for this indication is supported.
Key findings — cited to the page
| Grade 3 or 4 neutropenia (%) | 28.5 % | · p.66 |
| Participants with Grade 3 or 4 neutropenia in Dose 2 | 3 | DRI13925 Portion 1 · p.35 |
| Participants with Grade 3 or 4 neutropenia in Dose 1 | 3 | DRI13925 Portion 1 · p.35 |
| Participants with Grade 3 or 4 neutropenia in Group A | 4 | DRI13925 Portion 1 · p.35 |
| Participants with Grade 3 or 4 neutropenia (%) | 32.3 % | · p.68 |
| Participants with Grade 3 or 4 neutropenia in Group B | 8 | DRI13925 Portion 1 · p.35 |
| Incidence of Grade 3 or 4 neutropenia | 28.5 % | DRI13925 Portion 1 · p.35 |
| Participants with Grade 3 or 4 neutropenia in Dose 3 | 6 | DRI13925 Portion 1 · p.35 |
| Percentage of Caucasian participants | 78.6 % | DRI13925 · p.43 |
| Study ID | DRI13925 | · p.5 |
| Polyarticular JIA (RF-) Frequency | 10–30% of all JIA | · p.8 |
| Positive Opinion Date | 14 November 2024 | Kevzara · p.6 |
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 →