Sanofi — Kevzara FDA Review (BLA761037, ORIG 1, 2017)
Sanofi · 2017 · FDA Review (openFDA) · company profile →
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The FDA review of Sanofi's Sarilumab (Kevzara) for moderately to severely active rheumatoid arthritis recommends approval, pending resolution of manufacturing deficiencies. Clinical trials consistently demonstrated Kevzara's efficacy in reducing RA signs and symptoms, improving physical function, and inhibiting structural damage, with the 200mg dose showing numerically greater benefits than the 150mg dose. The safety profile is consistent with other IL-6 receptor antagonists, with common concerns including infections, malignancy risk, GI perforation, and laboratory abnormalities (neutropenia, elevated liver enzymes, lipid changes). These risks are deemed manageable through labeling, including a Boxed Warning for serious infections. No new safety signals were identified, and no REMS or postmarketing cardiovascular outcome trial were deemed necessary.
Key findings — cited to the page
| Joint space narrowing grade range | 0 to 4 | · p.116 |
| Patients with grade 2 neutropenia in sarilumab group | 1 | ACT11575 · p.209 |
| Grade 4 ANC decreases (Tocilizumab q4w + DMARD) | 0 | · p.592 |
| Grade 4 lymphopenia threshold | < 0.2 Giga/L | · p.153 |
| Grade 3 ANC decreases (Sarilumab 150mg q2w + DMARD) | 4 % | · p.592 |
| Grade 3 ANC decreases (Sarilumab 200mg q2w + DMARD) | 10 % | · p.592 |
| Grade 3 or 4 neutropenia threshold | <1.0 Giga/L | · p.153 |
| Grade 1 lymphopenia threshold | ≥ 0.8 Giga/L-LLN | · p.153 |
| Grade 2 lymphopenia threshold | ≥ 0.5 Giga/L - < 0.8 Giga/L | · p.153 |
| Grade 3 lymphopenia threshold | ≥ 0.2 Giga/L - < 0.5 Giga/L | · p.153 |
| Grade 3 ANC decreases (Tocilizumab q4w + DMARD) | 1 % | · p.592 |
| Grade 4 ANC decreases (Sarilumab 150mg q2w + DMARD) | 2 % | · p.592 |
Source: Sanofi ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →