Argenx’s Vyvgart Hytrulo Secures Second US Approval for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

1. FDA Approval: The US FDA has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
2. Second US Indication: This marks the second US approval for Vyvgart Hytrulo, following its initial approval for generalized myasthenia gravis (gMG).
3. Rare Autoimmune Disease: CIDP is a rare and debilitating peripheral nervous system disorder that causes fatigue, muscle weakness, and loss of feeling in the arms and legs.
4. Mechanism of Action: Vyvgart Hytrulo works by inhibiting the neonatal FC receptors (FcRn) responsible for recycling IgG molecules, including autoantibodies, inside the body.
5. Clinical Trial Results: The late-stage ADHERE study showed that 69% of patients responded to Vyvgart Hytrulo, with a 61% reduction in the risk of relapse compared to placebo.
6. Commercial Expansion: Argenx is significantly expanding its commercial teams to support the CIDP launch, targeting 12,000 patients initially and aiming for a total addressable population of 24,000 treated CIDP patients.
7. Future Indications: Argenx plans to explore additional indications for Vyvgart, including seronegative generalized myasthenia gravis, immune-mediated myopathies, and Sjogren’s disease.