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.
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.
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.”
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.