Dutch immunology company argenx has received European Commission (EC) approval for Vyvgart (efgartigimod alfa) to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
Vyvgart alfa is a human IgG1 antibody fragment designed to reduce pathogenic IgG antibodies by blocking the IgG recycling process.
The EC approval allows patients previously treated with corticosteroids or immunoglobulins to receive Vyvgart as a subcutaneous injection (SC) monotherapy.
Available in vial or prefilled syringe form, the novel therapeutic can be administered by patients, caregivers, or healthcare professionals.
The treatment begins with a weekly dose regimen, which may be adjusted to every other week based on clinical evaluation.
It is the second European approval for Vyvgart SC, following its initial approval for treating generalised myasthenia gravis.
The approval applies to all 27 European Union (EU) member states, along with Iceland, Liechtenstein, and Norway.
Argenx chief medical officer Luc Truyen said: “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.”
The EC approval follows a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
It is based on positive results from ADHERE, a multi-centre, randomised, double-blind, placebo-controlled clinical trial in 322 adult patients, including 130 from Europe.
The study showed a 61% reduction in relapse risk compared to placebo.
Also, 66.5% of patients treated with Vyvgart SC showed clinical improvement in mobility, function, and strength.
The treatment showed clinical benefits across all patient subtypes, regardless of prior treatment, and a safety profile consistent with previous clinical studies.
ADHERE investigator Luis Querol said: “CIDP can severely affect quality of life by causing weakness, loss of balance and mobility, numbness, and pain in a patient’s arms and legs. For far too long, physicians have had limited options for helping to improve patient outcomes.
“The approval of Vyvgart SC for the treatment of CIDP marks a turning point in clinical practice, as physicians now have access to a new, effective treatment option that, for the first time, precisely targets a key mechanism of disease and provides meaningful functional improvements to patients.”
Earlier this year, Argenx received the US Food and Drug Administration (FDA) approval for a self-injection method to administer Vyvgart Hytrulo.
The new administration option is aimed at adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and those with CIDP.
