VYVGART (efgartigimod alfa) - Myasthenia

The Committee considers that the clinical benefit of VYVGART (efgartigimod alfa) 1,000 mg solution for injection in subcutaneous formulation is substantial only as an add-on to standard therapy, including first-line immunosuppressants, for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, who
remain symptomatic,

Considering:

• demonstration of the non-inferiority of efgartigimod alfa administered by the subcutaneous route compared to administration by the IV route, in terms of pharmacokinetics (percentage decrease in total IgG levels between baseline and day 29), demonstrated in an open-label study in patients with generalised myasthenia gravis (gMG), and the methodological reservations raised,
• the absence of comparative efficacy data versus efgartigimod IV,
• the similar short-term safety profile between the two administration routes, apart from injection site reactions, which were more common with SC administration of
  efgartigimod alfa compared to IV administration,
• uncertainties with respect to long-term safety,
• the absence of a formally demonstrated impact in terms of improvement in quality of life with the subcutaneous formulation compared to the IV formulation,

the Transparency Committee considers that VYVGART (efgartigimod alfa) 1,000 mg solution for injection in subcutaneous formulation provides no clinical added value (CAV V) compared to the proprietary medicinal product VYVGART 20 mg/mL (efgartigimod alfa) concentrate for solution for infusion.