VYVGART and VYVGART Hytrulo Show Promise in Treating Severe Autoimmune Diseases

Argenx, a global immunology firm, has unveiled promising Phase 3 ADHERE trial results for its drug VYVGART Hytrulo, used to treat chronic inflammatory demyelinating polyneuropathy (CIDP). The data was first presented at the American Academy of Neurology Annual Meeting, showcasing the potential of VYVGART Hytrulo as a significant treatment for CIDP patients, possibly marking the first major advancement in 30 years.

The ADHERE trial involved 322 adult CIDP patients and demonstrated that VYVGART Hytrulo could substantially reduce the risk of clinical deterioration and relapse, with a 61% decrease compared to placebo. Notably, the drug was well-tolerated, aligning with previous safety profiles from clinical trials. The study also indicated that IgG autoantibodies are likely pivotal in CIDP's pathology, suggesting that VYVGART Hytrulo's ability to eliminate pathogenic IgGs could lead to safer and more effective treatments.

In addition to the ADHERE trial's findings, argenx highlighted seven posters and presentations reinforcing VYVGART and VYVGART Hytrulo as transformative options for patients with generalized myasthenia gravis (gMG). Real-world evidence showed that gMG patients treated with VYVGART were able to notably cut down on steroid use within the first six months of treatment, which is crucial given the long-term side effects associated with steroids.

The FDA is expected to make a decision on VYVGART Hytrulo's supplemental Biologics License Application for CIDP treatment by June 21, 2024. If approved, it would provide a new treatment option for CIDP patients who face numerous diagnostic and therapeutic challenges.

Argenx's Chief Medical Officer, Luc Truyen, emphasized the company's innovative approach to autoimmunity research, which is redefining possibilities for patients and the immunology community globally. The ADHERE trial's principal investigator, Jeffrey Allen, also highlighted the importance of the findings, which could lead to the development of new treatments that are safe, effective, and well-tolerated.

The company's presentation at the AAN meeting also underscored the rapid, deep, and sustained improvements that VYVGART and VYVGART Hytrulo can bring to gMG patients, including the ability to lessen the burden of steroid use, a significant issue for those with autoimmune diseases.

VYVGART and VYVGART Hytrulo are both prescription medicines used to treat gMG in adults who test positive for antibodies against the acetylcholine receptor. They work by binding to the neonatal Fc receptor (FcRn) and reducing the levels of circulating IgG autoantibodies, which are believed to cause the disease's symptoms.

Argenx is dedicated to improving the lives of those suffering from severe autoimmune diseases and is advancing a portfolio of novel antibody-based treatments. The company's commitment to translating immunological breakthroughs into innovative medicines positions it at the forefront of the global immunology field.