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.”