VYVGART

What it is

Vyvgart (efgartigimod alfa) is a solution for injection in pre-filled syringe, with each pre-filled syringe containing 1,000 mg of efgartigimod alfa in 5.0 mL (200 mg/mL). Efgartigimod alfa is a human recombinant immunoglobulin G1 (IgG1)-derived Fc fragment produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Efgartigimod alfa is a human IgG1 antibody fragment engineered for increased affinity to the neonatal Fc Receptor (FcRn), and binds to FcRn, resulting in a reduction in the levels of circulating IgG including pathogenic IgG autoantibodies. Vyvgart is subject to additional monitoring in Australia.

Approved indications —

An add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. — Monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

Dosing overview

For generalised Myasthenia Gravis, the recommended dose is 1,000 mg administered subcutaneously in cycles of once weekly injections for 4 weeks, with subsequent treatment cycles administered according to clinical evaluation. For chronic inflammatory demyelinating polyneuropathy, the recommended dose is 1,000 mg administered subcutaneously as once-weekly injections, with treatment initiated at weekly dosing and adjustable to every other week based on clinical evaluation.

Key safety warnings

Efgartigimod alfa causes transient reduction in IgG levels, which may increase the risk of infections; the most common infections observed in clinical trials were upper respiratory tract infections and urinary tract infections, and patients should be monitored for clinical signs and symptoms of infections during treatment. In patients with an active infection, the benefit-risk of maintaining or withholding treatment should be considered until the infection has resolved, and if serious infections occur, delaying treatment should be considered until the infection has resolved. Injection reactions such as mild to moderate rash or pruritus may occur, and cases of anaphylactic reaction have been reported with efgartigimod alfa intravenous in the post-marketing setting; the first administrations of Vyvgart must be performed under the supervision of a healthcare professional, and patients should be monitored for 30 minutes after administration for clinical signs and symptoms of injection reactions. For patients being treated with efgartigimod alfa, vaccination with live or live-attenuated vaccines is generally not recommended; if such vaccination is required, these vaccines should be administered at least 4 weeks before treatment and at least 2 weeks after the last dose of efgartigimod alfa.

Contraindications

Vyvgart is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

No information regarding PBS listing details (strength, item count, restriction type, or ex-manufacturer price) is provided in the source documents.

Regulatory history

Vyvgart efgartigimod alfa 1000 mg/5 mL solution for injection prefilled syringe was first listed on the ARTG on 2026-02-20. An AusPAR (Australian Public Assessment Report) was approved on 2025-02-21 for the indication of an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The PBAC recommended Vyvgart in March 2025 for generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor antibody positive.