The US Food and Drug Administration (FDA) has approved Argenx‘s VYVGART Hytrulo to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
Intended for use as a once-a-week 30-to-90-second subcutaneous injection, VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for this indication.
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In February 2024, the US regulator accepted Argenx’s sBLA for VYVGART Hytrulo to treat CIDP, for priority review.
The FDA’s decision is grounded on results from the ADHERE study.
The study demonstrated that 69% of subjects treated with VYVGART Hytrulo, irrespective of prior treatment, showed clinical improvement including enhanced mobility, function and strength.
The trial also met its primary endpoint with a statistically significant 61% reduction in the risk of relapse compared to placebo.
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By GlobalData99% of trial participants chose to continue in the ADHERE open-label extension.
The safety profile of VYVGART Hytrulo was in line with prior clinical studies and its real-world use, without any new safety concerns reported.
VYVGART Hytrulo is also approved in the US for generalised myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.
argenx chief medical officer Luc Truyen stated: “argenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity.
“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. The 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.”
