argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP.

“argenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “Patients have been waiting, and today argenx is delivering the first innovative treatment for CIDP in more than 30 years. VYVGART Hytrulo is a precision tool that has been shown to drive meaningful benefits for patients. Today’s FDA approval means that CIDP patients have a transformational new treatment option and further affirms the therapeutic profile of VYVGART Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.”

CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. Many patients become wheelchair bound and are unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability.

“While CIDP patients face many daily concerns and challenges, fear of disease progression should not be one of them. CIDP can be debilitating and have significant impact on quality of life and many patients with CIDP require treatments that may be burdensome. The approval of this promising new treatment option for CIDP may provide hope to patients that they can treat their disease beyond just managing symptoms. CIDP patients deserve treatment options and we look forward to a future of choices for optimal and individualized care,” said Lisa Butler, Executive Director, GBS|CIDP Foundation.

“Today marks a groundbreaking day for the treatment of CIDP. Existing treatments have been limited to corticosteroids and plasma-derived therapies. These treatments, while effective for many patients, can be challenging for some patients to receive,” said Jeffrey Allen, M.D., Professor, Department of Neurology,

University of Minnesota and Principal Investigator in the ADHERE trial. “Today’s approval of VYVGART Hytrulo gives doctors and patients a new, safe and effective treatment option that may lessen the burden of treatment that some patients experience.”

The FDA approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. Ninety-nine percent of trial participants elected to participate in the ADHERE open-label extension. The safety results were generally consistent with the known safety profile of VYVGART in previous clinical studies and real-world use.

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.

Access to VYVGART Hytrulo

argenx is committed to supporting access for patients to its medicines and VYVGART Hytrulo is expected to be available for patients in the U.S. immediately. The typical patient will have an annual out-of-pocket cost similar to that of a VYVGART or VYVGART Hytrulo patient with gMG, or an IVIg patient with CIDP.

argenx has established a patient support program, My VYVGART Path, which can help patients and HCPs navigate access. My VYVGART Path program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. More information is available at VYVGART.com.

Conference Call Details

argenx will host a conference call Friday, June 21, 2024, at 11:00 pm CET (5:00pm ET) to discuss the approval. A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

Dial-in numbers:

Please dial in 15 minutes prior to the live call.