Already thriving with a successful launch of infused Vyvgart and its subcutaneous follow-on Vyvgart Hytrulo to the tune of $2.2 billion in sales last year, argenx has scored FDA approval for a new formulation of the treatment, which gives patients the option of administering it at home.
The U.S. regulator has signed off on argenx’s prefilled syringe (PFS) version of Vyvgart Hytrulo, which allows patients to self-inject at home as opposed to undergoing infusions or making weekly trips to the doctor’s office to receive a shot. The drug is currently approved in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
“We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility,” Luc Truyen, M.D., Ph.D., argenx’s chief medical officer, said in a release. “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.”
William Blair analyst Myles Minter, Ph.D., and Citi analyst Samantha Semenkow, Ph.D., said in notes to clients that the self-administration option will be a “growth driver” in both indications for Vyvgart.
“For gMG, we anticipate expansion in earlier lines of therapy and in patients that found weekly cycled dosing of Vyvgart administered by physicians burdensome,” Semenkow added. “In CIDP, given weekly dosing, we believe PFS availability will expand market share particularly for patients previously uninterested in weekly in-office dosing.”
In December of 2021, Amsterdam-based argenx scored its first-ever FDA approval with Vyvgart, a first-in-class FcRn inhibitor. Until Vyvgart's approval, doctors had to rely on surgery, steroids and chemotherapy to treat gMG.
In June of 2023, the FDA signed off Vyvgart Hytrulo, the treatment’s Halozyme-partnered, subcutaneous version. A year later, argenx followed with an FDA label expansion to treat CIDP.
Other treatments on the market for gMG include AstraZeneca’s Ultomiris and UCB’s FcRn entry Rystiggo, which were approved in the indications in 2022 and 2023, respectively.
Johnson & Johnson is closing in on an approval for its FcRn candidate nipocalimab, which was gained in a $6.5 billion buyout of Momenta Pharmaceuticals in 2020.
“While other options for CIDP and MG are in development, we believe availability of the prefilled syringe formulation, with self-administration, adds to argenx’s already large competitive moat in the indications,” Minter wrote. “Argenx remains in the lead commercial position, with Vyvgart annualizing about $3 billion and growing 97% year-over-year, and we expect this growth to be bolstered with today’s approval.”