Policy & Regulation
argenx reports FDA acceptance of BLA for subcutaneous efgartigimod in gMG with priority review
22 November 2022 -

Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) announced on Tuesday that the US Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG).

SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology. ENHANZE facilitates the SC injection delivery of biologics that are typically administered via intravenous (IV) infusion.

The submission was based on positive results from a Phase 3 study which demonstrated the noninferiority of the pharmacodynamic (PD) effect of SC efgartigimod as compared with IV administered VYVGART in adult patients with gMG.

The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of 20 March 2023.



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