Pharma Focus Europe

FDA Approves Argenx's VYVGART® Hytrulo With ENHANZE® for Subcutaneous Use in Generalized Myasthenia Gravis, Announced by Halozyme

Wednesday, June 21, 2023

Halozyme Therapeutics, Inc. (NASDAQ: HALO) has announced that argenx has received approval from the U.S. Food and Drug Administration (FDA) for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE®. The FDA approval allows for the subcutaneous (SC) use of VYVGART® Hytrulo in the treatment of generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor (AChR) antibodies.

VYVGART® Hytrulo is a combination product consisting of efgartigimod alfa, a human IgG1 antibody fragment marketed as VYVGART® for intravenous use, and recombinant human hyaluronidase PH20 (rHuPH20), which is Halozyme's ENHANZE® drug delivery technology used to facilitate the subcutaneous delivery of biologics. The treatment involves a once-weekly subcutaneous injection of a fixed dose (1,008 mg), administered by a healthcare professional over a period of 30-90 seconds, for a total of four weeks.

Dr. Helen Torley, the president and chief executive officer of Halozyme, expressed her satisfaction with argenx's FDA approval for the subcutaneous form of efgartigimod. She emphasized the expanded treatment options and increased flexibility that this approval brings for patients with gMG. Dr. Torley also mentioned the anticipation for upcoming data readouts on the subcutaneously administered efgartigimod in other autoimmune conditions, which have the potential to expand the number of approved indications and benefit more patients.

The FDA approval is based on positive results from the Phase 3 ADAPT-SC study, which demonstrated the efficacy of VYVGART® Hytrulo by effectively reducing anti-AChR antibody levels in adult gMG patients to a similar extent as intravenous VYVGART®. The ADAPT-SC study served as a bridge to the Phase 3 ADAPT study, which formed the basis for the approval of intravenous VYVGART® in December 2021.

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