Argenx, a biotechnology company based in the Netherlands, announced that the US Food and Drug Administration (FDA) has approved a self-injection method for VYVGART Hytrulo.
This option is aimed at adult patients with generalised myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies and those with chronic inflammatory demyelinating polyneuropathy (CIDP).
Argenx chief medical officer Luc Truyen said: “Today’s FDA approval provides a new self-injection option across both approved indications in the US that is designed for patients who seek more independence with their treatment.
“We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer VYVGART Hytrulo.
“Whether patients prefer to receive their treatment in a physician’s office, at home, or while travelling, they can experience treatment on their own terms and continue to benefit from VYVGART Hytrulo’s favorable safety profile and strong efficacy.”
The prefilled syringe includes efgartigimod alfa and hyaluronidase-qvfc and can be administered subcutaneously in 20 to 30 seconds by patients, caregivers, or healthcare providers, following appropriate training.
This self-injection solution was developed through argenx’s exclusive partnership with Halozyme, using the ENHANZE drug delivery technology to enable rapid administration of biologics in larger volumes.
The FDA’s approval followed studies showing that the prefilled syringe is bioequivalent to the vial form of VYVGART Hytrulo.
Additionally, human factors validation studies confirmed that patients with gMG or CIDP, or their caregivers, could safely and effectively use the prefilled syringe.
Earlier FDA approval for VYVGART Hytrulo in treating these conditions was based on data from the global Phase 3 ADAPT, ADAPT-SC, and ADHERE clinical trials.
In November last year, Zai Lab and argenx reported that China’s National Medical Products Administration (NMPA) had given the green light to the supplemental biologics license application (sBLA) for Vyvgart Hytrulo (1,000mg/5.6ml vial) [Efgartigimod Alfa Injection].
