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More Than Two Decades of UTSW Research Pave Way for First-In-Kind Drug

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Building on decades of basic research at UT Southwestern Medical Center, the Food and Drug Administration has approved a first-in-kind immune modulating drug known as efgartigi­mod alfa-fcab. The therapeutic is a new treatment for adults with a form of myasthenia gravis, a rare and chronic autoimmune disease characterized by debilitating and potentially life-threatening muscle weakness.

Between 1990 and 2015, former UTSW Pro­fessor of Immunology E. Sally Ward, Ph.D., headed the research that laid the groundwork for the drug’s approval. In clinical trials, 68% of pa­tients with anti-acetylcholine receptor antibody positive myasthenia gravis responded to efgartigimod, compared with 30% of those taking a placebo. The global immunology company argenx has licensed the drug’s patent rights and is exploring the possibility of treating other conditions mediated by immunoglobulin G (IgG).

Efgartigimod is Dr. Ward’s second commercial success based on research conducted while at UTSW. Her work also led to tech­nology that can extend the half-life of therapeutic antibodies currently used in the FDA-approved drug ravulizumab and two antibody ther­apies against COVID-19, as well as another antibody in development to treat respiratory syncytial virus (RSV).