SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics Inc's (NASDAQ: HALO) ENHANZE drug delivery technology.
ENHANZE facilitates the subcutaneous injection delivery of biologics that are typically administered via intravenous (IV) infusion.
The submission package includes data from the Phase 3 ADAPT-SC study evaluating the noninferiority of SC efgartigimod compared to intravenously administered Vyvgart.
ADAPT-SC met its primary endpoint of total IgG reduction from baseline at day 29, demonstrating noninferiority of SC efgartigimod to Vyvgart.
Patients treated with SC efgartigimod achieved a mean total IgG reduction of 66.4% from baseline at day 29, compared to a 62.2% reduction with Vyvgart.
Results were consistent across the overall population.
Further, 69.1% of patients treated with SC efgartigimod showed improved quality of life scores.
The safety profile for SC efgartigimod was consistent with the ADAPT study.
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