Argenx secures TGA approval in autoimmune disease: Will it holds its own against rivals?

The Therapeutic Goods Administration (TGA) has approved argenx’s FcRn inhibitor, Vyvgart (efgartigimod alfa), for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive.

The medicine, which serves as an add-on to standard treatment, is now set to be reviewed for reimbursement under the Pharmaceutical Benefits Advisory Committee (PBAC) agenda in March 2025.

“The approval of Vyvgart for gMG patients in Australia is an important milestone for patients who are seeking access to a treatment with the potential to allow them to return to normal activities of daily living,” said Kathryn Evans, General Manager for argenx Australia. “We are grateful to the patients and advocates who have worked alongside us and who are now one step closer to having access for the first time to the precision of an FcRn blocker in Australia.”

Despite advances in treatment, unmet needs remain significant for Australian gMG patients. A recent survey conducted by Myasthenia Alliance Australia (MAA) revealed that nearly half of respondents felt their symptoms were not well controlled with existing therapies.

“Furthermore, 79% of patients said that it was extremely important to them that new treatments were offered, while experts estimated that 30% of Australian patients are currently living in a refractory state, demonstrating the high demand for innovative therapies like Vyvgart,” said MAA Chair Susan White.

A/Professor Sean Riminton, Clinical Immunologist in Sydney, highlighted the challenges patients face with current treatment options.

“gMG patients lack sufficient treatment options,” he said. “Patients and healthcare providers are currently relying on steroids or IVIg to manage symptoms related to gMG, exposing patients to steroid-related adverse effects. The potential to treat gMG patients with Vyvgart is a welcome development.”

However, argenx faces competition in the local market. At the upcoming PBAC meeting, UCB’s Rystiggo (rozanolixizumab) will also be under review, alongside resubmissions from Alexion and UCB for Ultomiris (ravulizumab) and Zilbrysq (zilucoplan), respectively. While these treatments have already secured TGA approval, the PBAC will evaluate the funding and prescribing criteria for gMG patients.

Karen Massey, Chief Operating Officer at argenx, reinforced the company’s commitment to patient access, stating, “We believe that innovation has no meaning unless it reaches patients.”

Vyvgart is available in both intravenous and subcutaneous formulations, requiring administration at a clinic or infusion centre followed by 30 minutes of monitoring for allergic reactions. In the US, argenx is seeking regulatory approval for a prefilled syringe version, which would allow patients to self-administer the treatment, potentially increasing accessibility and convenience.

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