Details
The FDA initiated this study in the Sentinel System to investigate whether in utero exposure to fingolimod, indicated for the treatment of relapsing forms of multiple sclerosis (MS), is associated with an increased risk of cardiac and urinary malformations. This study was prompted by interim reports from the Gilenya Pregnancy Registry, conducted as a postmarketing requirement, which indicated a higher prevalence of congenital malformations, specifically cardiac and urinary, among infants exposed to fingolimod in utero compared to the general U.S. population and infants born to mothers with untreated MS.
The primary objective of this study was to assess the risk of cardiac and urinary congenital malformations in live births from pregnant women exposed to fingolimod during the first trimester of pregnancy. Results indicated an insufficient number of pregnant women exposed to fingolimod during the first trimester or during the 45-day pre-pregnancy period to reach any informative conclusions regarding the risk of congenital malformations.
The results supported FDA’s evaluation of the pregnancy safety signal pertaining to in utero fingolimod exposure.