FDA approved Vyvgart for Myasthenia Gravis
FDA announced that it had approved Vyvgart (efgartigimod) for generalized myasthenia gravis (gMG). The drug is indicated in adult patients who are positive for anti-acetylcholine receptor (AChR) antibody.
The approval is based on a 26-week placebo-controlled study that evaluated the efficacy versus placebo. More patients responded to Vyvgart (68% )compared to placebo (30%). Further, more patients responded to the muscle weakness versus placebo.
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Vyvgart is a new class of drug indicated for gMG. It is an antibody fragment that attaches to the neonatal Fc receptor (FcRn), thereby preventing immunoglobulin G (IgG) from entering the blood.
The product has received fast-track designation and orphan designation.