A global pharmacovigilance analysis of 354 pregnancies reported no new safety signals for ravulizumab, a complement inhibitor, aligning outcomes with the established profile of eculizumab. The analysis extends safety evidence specifically into a high-stakes population where data has historically been limited. For plasma complement therapies, the report supports the broader effort to strengthen pregnancy registries and real-world evidence for mechanistically similar agents. It also reinforces regulatory reliance on aggregated post-marketing datasets to assess risk when randomized pregnancy trials are not feasible.
Get the Daily Brief