AstraZeneca PLC — Saphnelo EMA EPAR public assessment report (EMEA/H/C/004975, 2022)
AstraZeneca PLC · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for AstraZeneca's Saphnelo (anifrolumab) for moderate to severe systemic lupus erythematosus (SLE) based on a positive CHMP opinion. The report details the manufacturing, quality control, and non-clinical safety, including toxicology studies in cynomolgus monkeys that identified potential reproductive risks and theoretical carcinogenicity. Clinical pharmacology showed consistent pharmacokinetics, with the 300 mg dose proving optimal for efficacy and pharmacodynamic neutralization. Efficacy was demonstrated through improved BICLA response rates and steroid tapering in Phase III studies, despite some challenges in trial design. Safety concerns include increased incidence of infections (particularly herpes zoster), hypersensitivity, infusion-related reactions, and a numerically higher incidence of malignancies, which will be monitored post-marketing. Overall, the benefit-risk profile was deemed acceptable.
Key findings — cited to the page
| Leukocyte IFN stimulation increase in IL-6, IP-10, MCP-1 and MCP-2 production | 3 to 19 fold | · p.27 |
| IC80 for maximum inhibition of PD signature production | 3.88 µg/ml | · p.57 |
| KD for FcRn (anifrolumab) | 2.63 μM | · p.26 |
| KD for FcRn (9D4) | 2.37 μM | · p.26 |
| Number of nonclinical in vivo studies with surrogate anti-IFNAR1 MAb | 2 | · p.25 |
| Number of nonclinical toxicity studies where PK was characterized | 6 | · p.25 |
| Female to male ratio in SLE | ~9:1 | · p.14 |
| CHMP positive opinion date | 16 December 2021 | Saphnelo (anifrolumab) · Europe · p.13 |
| Disease onset in childhood for SLE | 15%-20% | · p.14 |
| Standardised mortality ratio in SLE | 2.4 | · p.14 |
| Number of nonclinical pharmacology studies | 11 | · p.25 |
| Increased incidence/prevalence in non-Caucasians | 2 to 3 times higher | · p.14 |
Source: AstraZeneca PLC ↗ · 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 →