Pharma Focus America

Argenx Receives FDA Approval for VYVGART in Treating Chronic Inflammatory Demyelinating Polyneuropathy

Saturday, June 22, 2024

Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company, has received approval from the U.S. Food and Drug Administration (FDA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This makes it the first FcRn blocker approved for CIDP treatment.

Argenx, highlighted their commitment to addressing severe autoimmunity, noting VYVGART Hytrulo's potential to significantly benefit CIDP patients. He emphasized its role as a precise treatment tool and a new therapeutic option for patients who have been awaiting innovative solutions.

CIDP is a rare autoimmune disorder affecting the peripheral nervous system, causing symptoms like muscle weakness, fatigue, and mobility issues. Current treatments, such as corticosteroids and plasma-derived therapies, can be challenging for patients. VYVGART Hytrulo's approval represents a promising alternative, backed by positive results from the ADHERE Study, the largest CIDP clinical trial conducted to date.

Results from the ADHERE trial showed that 69% of patients treated with VYVGART Hytrulo demonstrated clinical improvement, with a significant reduction in relapse risk compared to placebo. Safety findings were consistent with previous studies, indicating a favorable safety profile.

VYVGART Hytrulo is also approved in the U.S. for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.

argenx is committed to ensuring patient access through initiatives such as the My VYVGART Path program, offering support for education, access, and financial assistance.



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