argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication

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Editor's note: this story was originally published on BioPharmInternational.com.

FDA has approved Netherlands-based immunology company argenx's VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This is the third indication for the biologic approved by FDA, making it the first and only neonatal Fc receptor (FcRn) blocker that has been approved for treating CIDP, the company announced on June 21, 2024. The approval is for a once weekly 30-to-90 second subcutaneous injection.

FDA’s approval is based on a clinical study (ADHERE) in which it was demonstrated that 69% of patients treated with VYVGART Hytrulo showed evidence of clinical improvement, regardless of whether or not they had had prior treatment. Improvements in mobility, function, and strength were demonstrated. The clinical trial, which the company stated is the largest clinical trial to date studying CIDP, met its primary endpoint in demonstrating a 61% reduction in the risk of relapse versus placebo.

“argenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity,” said Luc Truyen, MD, PhD, chief medical officer, argenx, in the press release. “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 [immunoglobulin G]-mediated autoimmune diseases.”

CIDP is a progressive immune-mediated neuromuscular disorder of the peripheral nervous system (1). It is a rare and debilitating condition in which 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. Currently, 85% of patients with CIDP require ongoing treatment, and nearly 88% of treated patients continue to 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, in the press release.

“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,” Jeffrey Allen, MD, professor, Department of Neurology, University of Minnesota, and principal investigator in the ADHERE trial, added. “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.”

VYVGART Hytrulo is also approved in the United States for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

For access to the treatment, argenx has established a patient support program, called My VYVGART Path, to help patients and health care providers navigate access. The program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients.

Reference

1. Gogia, B.; Rocha Cabrero, F.; Khan Suheb, M. Z.; et al. Chronic Inflammatory Demyelinating Polyradiculoneuropathy. (Updated March 4, 2024). In StatPearls [Internet]; StatPearls Publishing, 2024.

Source: argenx