Halozyme Therapeutics announced that argenx received FDA approval for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE® for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
VYVGART® Hytrulo is a subcutaneous product combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics. The product is to be administered subcutaneously by a healthcare professional as a single injection (1,008 mg fixed dose) over 30-90 seconds in cycles of once weekly injections for four weeks.
"We are pleased that argenx has received FDA approval for the subcutaneous form of efgartigimod, which reinforces their commitment to the patient community with a broadening of treatment options that brings flexibility for patients," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to the multiple data readouts this year for subcutaneously administered efgartigimod in additional autoimmune conditions, with the potential to expand the number of approved indications and eligible patients."
This FDA approval is based on positive results from the Phase 3 ADAPT-SC study, which established the efficacy of VYVGART® Hytrulo by demonstrating a reduction in anti-AChR antibody levels comparable to intravenous VYVGART® in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of intravenous VYVGART® in December 2021.
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