The VYVGART
Pregnancy Study

Welcome to the VYVGART Pregnancy Study

The VYVGART pregnancy study was set up by argenx BV, the manufacturer of VYVGART^® (efgartigimod alfa-fcab) and VYVGART^® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)*. VYVGART and VYVGART HYTRULO were approved by the Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the AChR antibody.

The purpose of this pregnancy study is to collect valuable information on pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy, and to follow the outcomes of those pregnancies. Women exposed to efgartigimod during breastfeeding will also be eligible for this pregnancy study.

argenx BV has engaged United BioSource LLC (UBC) (https://ubc.com) to help facilitate the Pregnancy Study through the utilization of the VYVGART website. UBC will only collect and use relevant personal information on behalf of argenx BV as a data processor and cannot use such information for its own purposes, as argenx BV maintains its role as a sponsor of the study and responsible data controller.

Your participation in this study will help argenx BV to determine if there are any possible effects of VYVGART in pregnant women or babies whose mothers were exposed to VYVGART during pregnancy and/or breastfeeding. The study data will be provided to regulatory agencies and healthcare providers treating women with gMG so that other women who become pregnant while being treated with VYVGART can better understand any possible effects of efgatigimod on pregnant women and their babies.

*The pregnancy safety study is open to pregnant subjects who have received either Vyvgart (efgartigimod alfa-fcab) or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) - referred to as "efgartigimod" or "Vyvgart" interchangeably throughout this site and study documents.