The FDA approval was based on the findings from the Phase 3 ADAPT-SC study that validated the efficacy of VYVGART Hytrulo as it showed a reduction in anti-AChR antibody levels comparable to intravenous VYVGART in adult gMG patients
FDA approves VYVGART Hytrulo injection for SC use in generalised myasthenia gravis treatment. (Credit: argenx)
Dutch immunology company argenx has received approval from the US Food and Drug Administration (FDA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to treat generalised myasthenia gravis (gMG).
VYVGART Hytrulo is an injection for subcutaneous (SC) use for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
The FDA approval was based on the findings from the Phase 3 ADAPT-SC study.
The results validate the efficacy of VYVGART Hytrulo as it showed a reduction in anti-AChR antibody levels comparable to intravenous VYVGART in adult gMG patients.
According to the Dutch firm, ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for the approval of intravenous VYVGART in December 2021.
In the study, the primary endpoint of noninferiority in the ADAPT-SC study was achieved, and at day 29, VYVGART Hytrulo showed a mean total IgG reduction of 66.4% from baseline compared to VYVGART’s 62.2%.
Additional key secondary endpoints were also achieved. They aligned with the effectiveness metrics from the ADAPT research that established a link between the decrease in total IgG and the clinical benefit in gMG.
The safety profile was also consistent with the ADAPT clinical trial except for injection site reactions.
argenx chief medical officer Luc Truyen said: “Today’s approval of VYVGART Hytrulo is another significant milestone on our path to redefine what well-controlled means for gMG patients.
“The availability of a second argenx innovation in just 18 months also underscores our longstanding commitment to the gMG community by providing more choice and flexibility in how patients receive treatment.
“With our broad gMG offering of both a first-in-class infusion and SC injection, we continue to offer an individualised treatment approach and the possibility of staying symptom-free, while providing patients options of how and where they want to seek treatment.”
VYVGART Hytrulo is a subcutaneous product combination of efgartigimod alfa and recombinant human hyaluronidase PH20, Halozyme’s ENHANZE drug delivery technology to enable subcutaneous delivery of biologics.
The product is intended to be administered subcutaneously as a single injection (1,008 mg fixed dose) over 30-90 seconds in cycles of once-weekly injections for four weeks.