The U.S. Food and Drug Administration (FDA) approved Vyvgart Hytrulo in June 2023 to treat adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor. With that decision, Vyvgart Hytrulo became the first therapy administered via an under-the-skin injection to gain approval in the U.S. for gMG.
According to exploratory data from the ADAPT-SC trial, which supported the approval of Vyvgart Hytrulo for people with generalized myasthenia gravis (gMG), some patients may see results as early as one week after the last injection of a treatment cycle. However, each patient is unique and may respond differently to a given treatment; thus, a discussion with their healthcare team can help gMG patients better understand how Vyvgart Hytrulo may help in their particular case.
There are no available data on the use of Vyvgart Hytrulo during pregnancy in humans. In animal studies, administration of efgartigimod alfa and hyaluronidase — both components of Vyvgart Hytrulo — were generally not associated with adverse developmental effects during pregnancy or after birth. Yet, it’s recommended patients who are pregnant or planning to become pregnant talk with their healthcare providers to know if the therapy is safe during that period.
Efgartigimod alfa, a key component of Vyvgart Hytrulo, has been reported to have no or a negligible impact on a person’s ability to drive and use machines. Nevertheless, it’s recommended patients be careful before attempting to drive or use any machines until they know how Vyvgart Hytrulo affects them. Patients starting treatment with Vyvgart Hytrulo should talk with their healthcare team regarding the treatment’s potential impact on daily activities like driving.