Vyvgart Hytrulo prefilled syringe gets US regulatory approval
FDA OKs self-administered treatment for gMG
The U.S. Food and Drug Administration (FDA) has approved a version of Argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that can be self-administered via a prefilled syringe to treat generalized myasthenia gravis (gMG).
These prefilled syringes are indicated for adults with gMG who are positive for antibodies against the acetylcholine receptor, the most common type of MG-causing antibody, much like the previously approved formulation of Vyvgart Hytrulo and its predecessor, Vyvgart (efgartigimod alfa-fcab).
While the earlier versions required administration by a healthcare provider, the new syringes allow Vyvgart Hytrulo to be administered at home by a patient or caregiver after proper training.
The approval also covers adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease affecting the nervous system.
“Today’s FDA approval provides a new self-injection option … that is designed for patients who seek more independence with their treatment,” Luc Truyen, MD, PhD, chief medical officer at Argenx, said in a company press release. “Our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer Vyvgart Hytrulo.”
Latest step in regulatory approval
In myasthenia gravis (MG), the immune system mistakenly generates self-reactive antibodies that attack proteins needed for nerve-muscle communication. These antibodies belong to a class of antibodies circulating in the bloodstream known as immunoglobulin G (IgG).
The active ingredient in Vyvgart and Vyvgart Hytrulo is efgartigimod, an antibody fragment designed to accelerate the breakdown of MG-causing antibodies by blocking a protein that normally helps stabilize IgG antibodies in the bloodstream, called the neonatal Fc receptor.
By lowering the levels of these harmful antibodies, Vyvgart and Vyvgart Hytrulo aim to ease MG symptoms and overall disease severity and improve patients’ life quality.
Both are administered once weekly in four-week treatment cycles. Vyvgart was approved by the FDA in 2021. It’s given via into-the-vein infusions, lasting about an hour, by a trained healthcare professional.
Regulators approved Vyvgart Hytrulo, given via under-the-skin (subcutaneous) injections, in 2023. That administration method, which takes less than two minutes, was expected to be easier and more convenient than the infusions Vyvgart requires, but still necessitated preparation and administration by a healthcare professional.
The single-dose, prefilled syringes come ready to use, with the medication given as a 20- to 30-second subcutaneous injection by a healthcare provider, caregiver, or patient, provided the person has received training from a healthcare provider.
Both versions of Vyvgart Hytrulo were developed with Halozyme’s Enhanze delivery system, designed to enable rapid absorption of medications given subcutaneously.
“I am excited to offer my patients living with gMG and CIDP the option of the new prefilled syringe for Vyvgart Hytrulo,” said Beth Stein, MD, director of neuromuscular diseases at St. Joseph’s Health in Clifton, New Jersey. “A ready-to-use option enhances patient independence and reduces the time required for treatment, making disease management and control more seamless.”
The FDA’s approval of the prefilled syringe formulation was supported by data from studies that established it was bioequivalent to the original vial formulation of Vyvgart Hytrulo, meaning it has the same active ingredient and is expected to work the same way in the body as its predecessor.
Other studies showed the treatment could be safely and successfully prepared and administered by patients and caregivers, according to Argenx.
“Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from Vyvgart Hytrulo’s favorable safety profile and strong efficacy,” Truyen said.
The Myasthenia Gravis Foundation of America praised the FDA’s move.
“This new self-injection option is a natural progression, empowering individuals to take control of their treatment and working toward achieving a greater sense of normalcy in their lives,” said Samantha Masterson, the foundation’s president and CEO.
As with the other Vyvgart formulations, patients and healthcare providers considering the new prefilled syringe formulation will have access to the Argenx patient support program My Vyvgart Path, which offers resources, education, and financial assistance programs.
About the Author
