The European Commission (EC) has approved argenx’s Vyvgart (efgartigimod alfa) subcutaneous (SC) injection to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
The drug, developed with Halozyme’s proprietary recombinant human hyaluronidase enzyme, has been specifically authorised for use as a monotherapy in adults with progressive or relapsing active CIPD after previous treatment with corticosteroids or immunoglobulins.
CIPD is a rare autoimmune disease of the peripheral nervous system that can cause pain, fatigue, muscle weakness, and a loss of feeling in the arms and legs. Some paints can also become wheelchair bound and unable to work as the disease progresses.
Vyvgart SC, which is available as a vial or prefilled syringe and can be administered by a patient, caregiver or healthcare professional, is designed to reduce the pathogenic immunoglobulin G antibodies that have been shown to play a key role in the damage to the peripheral nerves.
argenx’s chief medical officer, Luc Truyen, said: “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.”
The EC’s decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the placebo-controlled ADHERE trial.
The study, which argenx said is the largest study of CIDP patients to date, showed that 66.5% of Vyvgart SC-treated patients had evidence of clinical improvement, including in mobility, function and strength.
There was a 61% reduction in the risk of relapse versus placebo, and clinical benefit was seen across all patient subtypes, regardless of prior treatment.
ADHERE investigator, Luis Querol, said: “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.”
Vyvgart SC is now authorised for two indications in Europe, following the EC’s approval of the drug as an add-on therapy for adults with generalised myasthenia gravis who are anti-acetylcholine receptor antibody positive.