The European Commission (EC) has approved argenx’s Vyvgart (efgartigimod alfa) 1000mg as a single agent for subcutaneous injection to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP), an immune-mediated neuromuscular disorder of the peripheral nervous system.
The decision allows the treatment to be used in those with progressive or relapsing active CIDP who have previously undergone corticosteroid or immunoglobulin therapy.
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Vyvgart, available in both vial and prefilled syringe forms, enables administration by caregivers, healthcare professionals and patients themselves.
The treatment commences with a weekly dose, which might be adjusted to fortnightly depending on the clinical response.
The approval is supported by the outcomes from the ADHERE trial, in which 66.5% of Vyvgart SC-treated subjects showed clinical improvements, with benefits observed in function, strength and mobility.
ADHERE met its primary goal, showing a 61% decrease in the relapse risk against a placebo.
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By GlobalDataThe safety outcomes aligned with the established safety profile from previous studies.
The therapy will now become available in the 27 European Union member states, along with Liechtenstein, Norway and Iceland.
The company is collaborating with regional regulatory authorities to facilitate patient access to the treatment.
argenx chief medical officer Luc Truyen stated: “Vyvgart SC is the first therapy with a novel mechanism of action to be approved for this community in more than 30 years.
“With Vyvgart SC, CIDP patients and physicians across Europe will soon have access to an effective novel therapy with a favourable safety profile that has a precise mechanism of action and a convenient self-injection option. This approval further affirms the potential of efgartigimod in IgG-mediated autoimmune diseases.”
This is the second approval for the therapy in Europe and the first cleared for the treatment of generalised myasthenia gravis (gMG) in individuals positive for anti-acetylcholine receptor (AChR) antibodies.
The human immunoglobulin G1 (IgG1) antibody fragment, efgartigimod SC, works by attaching to the neonatal Fc receptor (FcRn) and inhibiting the process of IgG recycling.
