FDA approves subcutaneous injectable for myasthenia gravis

Subcutaneous injection

The US Food and Drug Administration (FDA) has given approval to Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with Enhanze for subcutaneous (SC) use for the treatment of generalised myasthenia gravis (gMG).

The treatment is approved 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, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze drug delivery technology.

The product is to be administered subcutaneously by a healthcare professional as a single injection (1,008mg 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 III ADAPT-SC study, which demonstrated a reduction in anti-AChR antibody levels comparable to intravenous Vyvgart in adult gMG patients. ADAPT-SC was a bridging study to the Phase III ADAPT study, which formed the basis for approval of intravenous Vyvgart in December 2021.

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