The Novartis Safety Database collected cases from clinical trials and through a post-marketing phar- macovigilance non-interventional PRegnancy outcomes Intensive Monitoring (PRIM) study, where data from spontaneously reported pregnancies were collected using a set of targeted structured checklists. Pregnancy outcomes in women with MS exposed to ofatumumab during pregnancy or 6 months prior to last menstrual period (LMP) were analyzed and will be reported. Pregnancy and infant outcomes including congenital anomalies, infections, vaccinations, and developmental delays were collected from the reporting of pregnancy up to 1 year of infant age.At prior cutoff date of March-25-2022, there were 61 exposed pregnancies with 30 known outcomes and 17 live births after maternal exposure to ofatumumab during pregnancy or 6 months prior to LMP. No congenital anomalies, reports of B-cell depletion, immunoglobulin/hematological abnormalities, or serious infections were reported. Updated pregnancy outcomes with a cutoff date of Sep-25-2022 from the Database will be presented at the congress.Reporting the latest data on pregnancy outcomes after exposure to ofatumumab will provide informa- tion to healthcare professionals who treat people with MS of childbearing potential. In addition to the Novartis sponsored PRIM initiative, a prospective observational exposure registry on maternal and infant outcomes in patients exposed to ofatumumab is also underway.