The US Food and Drug Administration (FDA) has approved argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
The authorisation marks Vyvgart Hytrulo as the first and only neonatal Fc receptor blocker approved for the treatment of the rare autoimmune disease.
CIDP is a rare, debilitating and often progressive immune-mediated neuromuscular disorder of the peripheral nervous system that causes fatigue, muscle weakness and loss of feeling in the arms and legs.
Approximately 24,000 patients in the US are currently being treated for the condition, 85% of whom require ongoing treatment and nearly 88% of treated patients experiencing residual impairment and disability.
Approved as a once-weekly 30-to-90-second subcutaneous injection, Vyvgart Hytrulo works to reduce circulating immunoglobulin G (IgG).
The FDA’s decision was based on results from the ADHERE study, which evaluated Vyvgart Hytrulo in 322 adult patients with CIDP who were not on active treatment within the past six months, were newly diagnosed, or were being treated with either IgG therapy or corticosteroids.
Results demonstrated that 69% of patients treated with Vyvgart Hytrulo showed evidence of clinical improvement, including improvements in mobility, function and strength.
In addition, the study met its primary endpoint after demonstrating a 61% reduction in the risk of relapse versus placebo, with safety results being consistent with the known safety profile of Vyvgart in previous clinical studies.
The company has outlined that the combinative treatment is expected to be available for US patients immediately.
Luc Truyen, chief medical officer, argenx, commented: “We have generated strong clinical evidence that… Vyvgart Hytrulo can meaningfully improve and stabilise disease symptoms with a favourable safety profile and a simple route of administration.”
Vyvgart Hytrulo is already approved in the US to treat adult patients with generalised myasthenia gravis (gMG), a rare and chronic autoimmune disease, who are anti-acetylcholine receptor (AChr) antibody-positive.
More recently, argenx’s subcutaneous formulation of Vyvgart was authorised by the Medicines and Healthcare products Regulatory Agency for use as an add-on to standard therapy for adult gMG patients who are AChR antibody positive.
