European approval for argenx expands autoimmune footprint

European biotech argenx (Euronext: ARGX) has secured European Commission approval for Vyvgart (efgartigimod alfa) in chronic inflammatory demyelinating polyneuropathy (CIDP), marking the first regulatory green light for a novel mechanism in this condition in over three decades.

The injectable formulation, approved for adults with progressive or relapsing active CIDP who have previously received corticosteroids or immunoglobulins, can be administered by patients, caregivers, or healthcare providers. It is available as either a vial or prefilled syringe, with dosing beginning weekly and potentially adjusting to every other week based on clinical response.

CIDP is a rare, immune-mediated neurological disorder that damages peripheral nerves, leading to chronic weakness, numbness, and fatigue. Most patients require long-term treatment, and nearly nine in ten continue to experience significant disability despite therapy.