Netherlands-based Argenx BV has received approval from the United States Food and Drug Administration (FDA) for its Vyvgart (efgartigimod) intended to treat generalised myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody, it was reported on Friday.
gMG is a chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles (also called voluntary muscles) that worsens after periods of activity and improves after periods of rest.
Vyvgart is the first approval of a new class of medication and is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G back into the blood. The medication results in decrease in overall levels of immunoglobulin G (IgG), including the abnormal AChR antibodies that are present in myasthenia gravis.
The product's safety and efficiency were assessed in a 26-week clinical study of 167 patients with myasthenia gravis who were randomised to receive either the product or placebo.
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