FDA Approves Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP and gMG
The FDA has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for two indications: adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This is a subcutaneous formulation combining efgartigimod alfa, a neonatal Fc receptor blocker, with hyaluronidase to facilitate absorption. For gMG, it is administered in cycles of once-weekly injections for 4 weeks; for CIDP, it is given as once-weekly injections. The approval provides a subcutaneous option for these conditions, potentially offering convenience over intravenous alternatives. Clinicians should evaluate the need for age-appropriate vaccines before starting treatment due to transient IgG reduction.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Efgartigimod alfa is a neonatal Fc receptor blocker that reduces IgG levels. Hyaluronidase is an endoglycosidase that increases absorption of the co-administered drug.
Vyvgart Hytrulo is indicated for adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and chronic inflammatory demyelinating polyneuropathy (CIDP).
For gMG: Administer in cycles of once-weekly injections for 4 weeks. Prefilled syringe: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase subcutaneously over 20-30 seconds. Vial: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase subcutaneously over 30-90 seconds. Subsequent cycles based on clinical evaluation. For CIDP: Administer as once-weekly injections. Same doses as gMG. If a dose is missed, may be given up to 3 days after scheduled time. Not all patients respond; consider appropriateness of continuing if worsening of neurological symptoms. Prefilled syringe may be self-administered by patients/caregivers after instruction; vial is for healthcare professional use only. Do not administer intravenously. Do not dilute.
Trial data not available in label.
Vaccination: Evaluate need for age-appropriate vaccines before starting a new treatment cycle. Live vaccines are not recommended during treatment due to transient reduction in IgG levels. Not all patients respond; consider discontinuation if worsening of neurological symptoms in CIDP.
Vyvgart Hytrulo provides a subcutaneous treatment option for anti-AChR antibody-positive gMG and CIDP. It may be considered for patients who prefer subcutaneous administration or have difficulty with intravenous access. The need for vaccination assessment before each cycle is an important consideration.
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