FDA Approves Argenx's Vyvgart Hytrulo Prefilled Syringe For Self-Injection For At Home Use Setting

The U.S. Food and Drug Administration (FDA) on Thursday approved a new option for patients to self-inject Argenx SE’s ARGX Vyvgart Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) 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.

The single-dose prefilled subcutaneous injection was developed as part of argenx’s exclusive partnership with Halozyme Therapeutics Inc’s HALO Enhanze drug delivery technology, enabling rapid, high-volume biologics delivery.

Also Read: Argenx’s Flagship Drug Vyvgart Shows Sustained Disease Control In Rare Neuromuscular Disease Patients

The approval of the Vyvgart Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to Vyvgart Hytrulo in a vial.

In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered Vyvgart Hytrulo with the prefilled syringe. Previous FDA approval of Vyvgart Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC, and ADHERE trials.

William Blair writes the self-administration option will be a strong growth driver for the Vyvgart franchise in both MG and CIDP, enabling patients to have a high degree of flexibility and expanding the total addressable market.

The analyst writes that some patients could increase the frequency of dosing, given the convenience of self-administration, to achieve more continuous symptom relief, as reflected by the every-2-to-3-weeks dosing evaluated in the ADAPT-NXT trial. This could be another growth driver for the prefilled syringe.

“While other options for CIDP and MG are in development, including trials for prefilled syringe formulations, we believe Argenx's first-to-market advantage adds to its large competitive moat in both indications,” analyst Myles Minter wrote.

William Blair maintains Argenx with an Outperform rating.

Price Action: ARGX stock closed higher by 6.36% to $580.97on Friday.

Read Next: