Long-term safety of Orzen in Orzenic syndrome: evidence beyond 104 weeks
Across three cohorts with follow-up beyond two years, the safety profile remained consistent with the pivotal trial and no new signals were reported (García et al., 2025). Serious adverse events occurred in 8.1% of patients, in line with the 7.9% recorded at week 52 (López et al., 2023).
Registry data in 1,240 patients supports these findings, although follow-up beyond week 200 remains limited to a single European cohort (Müller et al., 2025).