The FDA Approves Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy

The Food and Drug Administration (FDA) has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; Argenx, Amsterdam, Netherlands) as a treatment for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart Hytrulo is a combination of efgartigimod alfa, a neonatal Fc receptor blocker (FcRn), and hyaluronidase-qvfc, an endoglycosidase. This is the first FcRn receptor blocker to be approved for the treatment of CIDP.

The approval is based on results from the ADHERE clinical trial (NCT04281472), evaluating the safety and efficacy of Vyvgart Hytrulo as a treatment for CIDP. This phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial included 322 adult participants with CIDP.

• Of participants treated with Vyvgart Hytrulo, 69% (n=322) showed evidence of clinical improvement which included mobility, function, and strength outcomes.
• The primary endpoint of ADHERE was met (P<.0001), as participants treated with Vyvgart Hytrulo demonstrated a 61% reduction in risk of relapse vs those treated with placebo (hazard ratio [HR], .39; 95% CI, .25 to .61).
• Vyvgart Hytrulo’s safety profile was consistent with that of intravenous Vyvgart, as established by clinical studies and real-world use.
• Of the 322 participants in ADHERE, 99% elected to participate in the trial’s open-label extension (OLE).

“VYVGART Hytrulo is a precision tool that has been shown to drive meaningful benefits for patients,” said Luc Truyen, MD, PhD, Chief Medical Officer of Argenx. “Today’s FDA approval means that CIDP patients have a transformational new treatment option and further affirms the therapeutic profile of VYVGART Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.”

In 2023, Vyvgart Hytrulo was approved for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies.