Vyvgart Hytrulo formulation available for generalized MG in US
Ready-to-use syringes are intended to be more convenient to use
The recently approved prefilled syringe formulation of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that offers the possibility of self-administration is now available in the U.S. for eligible adults with generalized myasthenia gravis (gMG) who have antibodies against acetylcholine receptors (AChRs).
These ready-to-use syringes are intended to be more convenient than Vyvgart Hytrulo’s previously approved formulation and its predecessor, Vyvgart, (efgartigimod alfa-fcab), both of which are cleared for the same patient group, but must be administered by a healthcare provider.
“Our prefilled syringe delivers on the current unmet need of patients who desire greater freedom and control in their day-to-day life,” a spokesperson for Argenx, the developer of Vyvgart and Vyvgart Hytrulo, said in a written Q&A with Myasthenia Gravis News.
A patient support program called My Vyvgart Path can help patients access the new formulation and other Vyvgart formulations. After enrollment, patients will be assigned a nurse case manager who can provide educational resources and support in understanding their insurance coverage and benefits. Financial assistance programs are also available, including copay assistance for people with commercial or private insurance through which patients may pay as little as $0 for treatment. Those without health insurance also may be able to receive coverage through My Vyvgart Path.
“We are bringing an important innovation to patients and our primary goal is providing broad access and optionality to patients and physicians to choose what is best for them,” the spokesperson said.
Convenience of new Vyvgart Hytrulo formulation
Both Vyvgart and Vyvgart Hytrulo contain the active ingredient efgartigimod, an antibody fragment that’s designed to block the protein neonatal Fc receptor, which normally helps stabilize certain antibodies in the bloodstream, including the self-reactive ones that disrupt nerve-muscle communication in myasthenia gravis (MG). In doing so, the treatment seeks to accelerate the breakdown of these harmful antibodies in order to ease MG symptoms of muscle weakness and fatigue.
Vyvgart and Vyvgart Hytrulo are given once weekly in four-week treatment cycles. Vyvgart, the first approved efgartigimod formulation, is given by an infusion into the bloodstream over about an hour, while the initially approved formulation of Vyvgart Hytrulo is given as injections under the skin that take less than two minutes. Although it was designed to offer more convenience than standard Vyvgart, that formulation still comes in single-dose vials that must be prepared and administered by a healthcare professional.
With the recently approved single-dose, ready-to-use syringes, the injections, which last 20-30 seconds, can be given by a caregiver or patient, if they receive appropriate training. That means patients won’t necessarily have to go to the clinic to receive treatment, although they can still choose it.
“Our priority is to empower patients with the choice of how and where they want to be treated and to engage their physician in shared treatment decisions, whether it’s self-injection at home, or administration in a physician’s office,” the spokesperson said.
Testing Vyvgart formulations in other patient populations
While all Vyvgart formulations are only approved for adults with gMG who have anti-AChR antibodies, the most common type of MG-causing antibodies, Phase 3 clinical trials are testing them in other patient populations.
ADAPT-OCULUS (NCT06558279) is testing the safety and efficacy of the prefilled syringe formulation of Vyvgart Hytrulo against a placebo in adults with ocular myasthenia gravis, where muscle weakness is limited to the eyes and eyelids. The study is enrolling about 124 participants at sites worldwide.
Meanwhile, ADAPT-SERON (NCT06298552), which is also recruiting globally, is exploring the safety and efficacy of standard into-the-vein Vyvgart against a placebo in about 110 adults with gMG who don’t have anti-AChR antibodies, those with less common antibody types or who don’t test positive for any disease-causing antibodies.
These Phase 3 studies are supporting Argenx’s pursuit of a label expansion for Vyvgart in order to “broaden its impact with the MG community.”
Meanwhile, two other Phase 2/3 clinical trials, ADAPT JR (NCT04833894) and ADAPT JR SC (NCT06392386), are evaluating the safety and pharmacological properties of Vyvgart formulations in children with gMG as young as 2. Both are expected to enroll about 12 children and are due to be completed in late 2026 or early 2027.
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