Argenx receives FDA approval for the first gMG subcutaneous treatment

Argenx receives FDA approval for the first gMG subcutaneous treatment

Source – Argenx 

Argenx has claimed an FDA clearance that might increase its market share in the increasingly competitive market for medications to treat the muscle-wasting condition known as generalized myasthenia gravis (gMG).

The Dutch biotech’s subcutaneous version of efgartigimod alfa, which is already used intravenously as Vyvgart to treat gMG, has received approval from the US agency.

The new formulation, known as Vyvgart Hytrulo and created in collaboration with Halozyme, is the country’s first subcutaneous treatment for gMG. Instead of a weekly, hour-long IV infusion given in a clinic, it enables a quick, one-minute injection given by a medical practitioner once each week.

With the exception of mild to severe injection site responses, the subcutaneous version of the FcRn blocker was generally well tolerated and shown to be equally as effective as the original Vyvgart at lowering levels of blood antibodies linked to gMG.

For adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, a category that comprises around 85% of the population, Vyvgart was authorized by the FDA for gMG in 2021, and the Hytrulo version has the similar label.

In 2022, the first full year that Vyvgart was on the market, Argenx announced sales of almost $400 million, and the product’s first-quarter 2023 sales of $218 million indicate that considerable growth is still expected.

Argenx’s chief executive Tim Van Hauwermeiren stated in the biotech’s first-quarter results update that subcutaneous Vyvgart will be essential to its aim of increasing sales in early-line gMG and enabling patients to get tailored treatment depending on their requirements.

While oral medications including cholinesterase inhibitors, corticosteroids, and immunosuppressant medications are frequently utilized as first-line treatments for gMG, the next step at the present for patients who require additional assistance is a transition to IV therapy.

According to Van Hauwermeiren, a subcutaneous option would be more appealing to certain people, and the new version will be useful in locations with restricted access to infusion clinics.

Additionally, applications for Vyvgart Hytrulo have been submitted in Europe and Japan. By the beginning of 2024, Argenx hopes to have both Vyvgart medicines authorized in all three countries. The subcutaneous form will first be sold in vials, but the business is also developing a prefilled syringe version that may one day enable patients to administer themselves at home.

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