argenx SE announced the FDA approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval introduces the first and only neonatal Fc receptor (FcRn) blocker for CIDP treatment, administered as a once weekly 30-to-90 second subcutaneous injection.
CIDP is a rare, progressive immune-mediated neuromuscular disorder affecting the peripheral nervous system, leading to significant mobility and sensory issues. The disease can severely impact patients' quality of life, with many becoming wheelchair-bound and unable to work as it progresses.
The FDA's approval is based on the ADHERE Study, the largest clinical trial for CIDP to date, which demonstrated that 69% of patients treated with VYVGART Hytrulo showed clinical improvement. The study met its primary endpoint with a 61% reduction in the risk of relapse compared to placebo. The safety profile of VYVGART Hytrulo was consistent with previous clinical studies.
VYVGART Hytrulo is also approved in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. argenx is committed to ensuring patient access to VYVGART Hytrulo, with a patient support program, My VYVGART Path, available to assist with access and financial assistance for eligible patients.
This approval represents a significant milestone in the treatment of CIDP, offering a new, safe, and effective treatment option that may reduce the burden of treatment for patients. argenx continues to focus on developing innovative treatments for severe autoimmune diseases, aiming to improve patients' lives through scientific advancements.
