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-weekly subcutaneous injection over 30 to 90 seconds, VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for this indication.
In February 2024, the US regulator accepted Argenx’s sBLA for VYVGART Hytrulo to treat CIDP, for priority review.
The FDA’s decision is based on the results of the ADHERE study.
The study showed that 69% of subjects treated with VYVGART Hytrulo, regardless of previous treatment, showed clinical improvement including increased 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.
99% of trial participants chose to continue in the open-label extension of ADHERE.
The safety profile of VYVGART Hytrulo was consistent with previous clinical studies and its real-world use, with no new safety concerns reported.
VYVGART Hytrulo is also approved in the US for generalized 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 bring significant benefits to patients. The FDA approval means CIDP patients have a new transformative treatment option and further confirms the therapeutic profile of VYVGART Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.
“FDA Approves Argenx’s VYVGART Hytrulo to Treat CIDP” was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.
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