Argenx Announces U.S. FDA Approval of Vyvgart Hytrulo Injection for Subcutaneous Use in Generalized MG
What you need to know:
- Argenx announced FDA approval for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), a subcutaneous injection for adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive.
- Delivered via injection instead of through an IV infusion, the drug combines Vyvgart (efgartigimod alfa), which received FDA approval in December of 2021, and a drug delivery technology called Enhanze, or recombinant human hyaluronidase PH20 (rHuPH20), made by Halozyme.
- The treatment is approved as a single injection (1,008 mg fixed dose) to be administered by a healthcare professional; it is delivered under the skin over 30-90 second, once weekly for four weeks.
A phase three clinical trial deemed Vyvgart Hytrulo to be safe and effective, demonstrating a reduction in anti-AChR antibody levels comparable to intravenous Vyvgart in adult gMG patients.
For more information, talk to your health care provider.
Read the full press release [here].
