FDA Approves VYVGART Hytrulo for CIDP Treatment

The US Food and Drug Administration (FDA) has granted approval to Argenx’s VYVGART Hytrulo for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is notable for being the first FcRn (neonatal Fc receptor) blocker approved for this condition, designed to be administered as a once-a-week subcutaneous injection lasting between 30 to 90 seconds.

The approval by the FDA follows the acceptance of Argenx’s supplemental Biologics License Application (sBLA) for VYVGART Hytrulo earlier in February 2024, which was given priority review. The FDA's positive decision is based on data from the ADHERE study, which indicated significant clinical benefits. In this study, 69% of participants treated with VYVGART Hytrulo showed clinical improvements in mobility, function, and strength. The primary endpoint of the trial was also met, demonstrating a statistically significant 61% reduction in the risk of relapse compared to placebo participants. Additionally, an impressive 99% of trial participants opted to continue in the ADHERE open-label extension phase.

Safety data for VYVGART Hytrulo from the clinical trials and its real-world usage have been consistent, with no new safety concerns reported. This establishes that the safety profile of the drug aligns well with prior clinical findings.

VYVGART Hytrulo is not only approved for CIDP but also for generalized myasthenia gravis in adults who are positive for anti-acetylcholine receptor antibodies. This broadens its therapeutic applications, making it a versatile treatment option for multiple autoimmune conditions.

Luc Truyen, Argenx’s chief medical officer, highlighted the significance of this approval, emphasizing that it represents a major advancement for patients suffering from severe autoimmunity. He stated that VYVGART Hytrulo offers the first innovative treatment for CIDP in over three decades, delivering meaningful clinical benefits. The FDA's endorsement of this drug is seen as a validation of its therapeutic profile and the potential of FcRn blockade in treating IgG-mediated autoimmune diseases.

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