argenx Secures Japanese Approval for VYVDURA in Treating Chronic Inflammatory Demyelinating Polyneuropathy

argenx SE, a prominent global immunology firm focused on advancing treatments for severe autoimmune disorders, has announced the approval of its innovative drug, VYVDURA, by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults suffering from chronic inflammatory demyelinating polyneuropathy (CIDP). This marks a significant milestone as Japan becomes the first country to provide access to argenx's VYVGART and VYVDURA portfolio across three medical indications, including generalized myasthenia gravis and CIDP.

VYVDURA is a groundbreaking medication that stands out as the only neonatal Fc receptor (FcRn) blocker approved for CIDP, a rare and debilitating neuromuscular disorder affecting the peripheral nervous system. This condition is characterized by symptoms like muscle weakness, fatigue, and sensory issues, which can severely impact mobility and quality of life. In many cases, patients become wheelchair-dependent as the disease progresses, with 85% requiring continuous treatment and 88% experiencing ongoing symptoms despite therapy.

The approval allows for a once-weekly subcutaneous injection of VYVDURA, which can be self-administered at home within 30 to 90 seconds. This convenience, coupled with the drug's established efficacy and safety profile, as demonstrated in the ADHERE trial and real-world evidence, offers a promising option for CIDP patients in Japan. According to argenx's Chief Medical Officer, Luc Truyen, M.D., Ph.D., this development represents a substantial advance in therapy for CIDP patients, who have seen little innovation in treatment over the past three decades.

The successful approval is underpinned by data from the ADHERE study, the most extensive clinical trial conducted for CIDP thus far. This trial included 322 participants and revealed that 69% of those treated with VYVDURA showed clinical improvements in mobility, strength, and overall function, irrespective of previous treatments. The trial met its primary endpoint with a 61% reduction in the risk of relapse compared to placebo, and nearly all participants opted for continued treatment in the open-label extension study, ADHERE+.

VYVDURA's journey began with its approval for manufacturing and marketing in January 2024, followed by its launch in April 2024 for generalized myasthenia gravis. In March 2024, it was designated as an Orphan Drug in Japan for CIDP treatment, highlighting its potential impact on a rare disease community.

The innovative formulation of VYVDURA combines efgartigimod alfa, an antibody fragment optimized for intravenous use, with recombinant human hyaluronidase PH20. This combination facilitates subcutaneous injection, reducing circulating IgG levels by targeting FcRn. As a first-of-its-kind treatment, VYVDURA offers a new approach to managing CIDP, reflecting argenx's commitment to enhancing the lives of those with severe autoimmune diseases.

argenx continues to leverage its expertise in immunology to develop and commercialize novel antibody-based therapies. Their portfolio includes the first approved FcRn blocker and other experimental medicines targeting various autoimmune disorders. This latest approval in Japan represents a significant step forward in their mission to deliver transformative treatments to patients worldwide.