Argenx's Flagship Drug Vyvgart Shows Sustained Disease Control In Rare Neuromuscular Disease Patients

Argenx SE ARGX showcased long-term data of Vyvgart (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile.

ADAPT-NXT Part B data demonstrated clinically meaningful improvements as early as Week 1 with Vyvgart’s bi-weekly and every three-week dosing schedules.

• Over the course of the study (126 weeks), 75% of patients showed sustained efficacy, achieving 2 points or more of improvement in MG activities of daily living (MG-ADL score) during more than 75% of study visits.
• In addition, more than half (56.5%) of participants achieved minimal symptom expression (MSE) during the study.

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Interim results of ADAPT-SC+ demonstrate consistent and repeatable improvements in MG-ADL (functional score) and MG Quality of Life (MG-QoL) scores in gMG patients treated with Vyvgart Hytrulo.

There was no observed increase in infections or injection-site reactions over nine treatment cycles. Also, the proportion of patients achieving MSE was consistent across multiple cycles.

ADHERE+ data demonstrated Vyvgart Hytrulo delivers long-term clinical efficacy.

The study showed functional improvements across aINCAT disability scores (>1-point), grip strength (>17 kPa), and the I-RODS scale (>8 points) at week 36 compared to baseline at entry to the standard of care withdrawal phase.

In addition, the majority of ADHERE patients who relapsed during randomized treatment withdrawal stage, restabilized on Vyvgart – 50% as early as week 4.

Argenx is pursuing label extension for Vyvgart, including through two Phase 3 studies for seronegative gMG (ADAPT-SERON) and ocular MG (ADAPT-OCULUS).

Price Action: ARGX stock is up 3.05% at $566.76 at the last check on Tuesday

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