ADVERTISEMENT
FDA Approves Efgartigimod Alfa/Hyaluronidase for CIDP Treatment
VYVGART Hytrulo (efgartigimod alfa/hyaluronidase) was recently approved by the Food and Drug Administration (FDA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
“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,” said Luc Truyen, MD, chief medical officer of drug manufacturer argenx.
>>NEWS: COVID-19 May Accelerate Brain Aging, Increase Neurological Risk
The once-weekly FcRn inhibitor injection is the first novel precision medicine for CIDP in over 3 decades. The approval was based on results from the Phase 3 ADHERE trial, a multicenter, randomized, double-blind, placebo-controlled trial of 322 adult patients with CIDP. Researchers found a 61% reduction in the risk of relapse with efgartigimod alfa/hyaluronidase versus placebo, and 69% of participants saw “some degree of clinical benefit, including improvements in mobility, function, and strength.”
“Patients with CIDP face a number of diagnostic and treatment challenges” said Jeffrey Allen, MD, Department of Neurology, University of Minnesota and Principal Investigator in the ADHERE trial. “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden. These findings enhance our understanding of the role that IgG autoantibodies are likely to play in the disease, and open the door to new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs.”
