Argenx Targets FDA Label Expansion After Vyvgart Trial Success

Argenx SE ARGX released topline data on Monday from the pivotal Phase 3 ADAPT SERON study of Vyvgart (IV: efgartigimod alfa-fcab).

Part A of the trial randomized participants (1:1) to receive 4 once-weekly infusions of efgartigimod IV or placebo, followed by a 5-week follow-up and primary analysis. Part B was an open-label extension: participants received 2 fixed cycles of 4 once-weekly efgartigimod infusions (4-week interval between cycles); from cycle 3 onward, additional cycles could be started ≥1 week after the last administration of the previous cycle, based on clinical status.

The study met its primary endpoint, demonstrating that AChR-Ab seronegative gMG patients treated with Vyvgart achieved a statistically significant and clinically meaningful improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo.

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sMG-ADL measures disease activity in patients living with myasthenia gravis, which evaluates the functional impact of symptoms on daily activities such as speaking, chewing, swallowing, breathing, and limb strength.

Argenx plans to submit a supplemental marketing application to the U.S. Food and Drug Administration (FDA) by the end of 2025, seeking expansion of the Vyvgart label to include adult AChR-Ab seronegative gMG patients across all three subtypes.

Detailed results from the ADAPT SERON study will be presented at an upcoming medical meeting.

Vyvgart was well tolerated and safe across AChR-Ab seronegative subtypes and consistent with the established safety profile in patients with AChR-Ab seropositive gMG and other indications. No new safety concerns were identified.

In April, the FDA approved a new option for patients to self-inject Vyvgart Hytrulo with a prefilled syringe for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Vyvgart Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional.

In April, Argenx showcased long-term data of Vyvgart (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of gMG and CIDP with a favorable safety profile.

Price Action: ARGX stock is trading higher by 2.73% to $678 premarket at last check Monday.

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