Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (Zolgensma^®) for the SMA Rare Disease: A Pharmacovigilance Study Based on the EMA Adverse Event Reporting System.

Following the surge in the Zolgensma ® -related ADR reporting in 2020 compared with 2019, the authors found a decreasing trend in the number of reports collected until 2022 in the US database, the Food and Drug Administration Adverse Event Reporting System (FAERS) [ 33 ].

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