The US health watchdog, the Food and Drug Administration (FDA), approved Vyvgart as an orphan drug. “There are significant unmet medical needs for people living with myasthenia gravis,” said Billy Dunn, chief of neuroscience within the regulator’s audit service. “Today’s approval is an important step in bringing a new therapeutic opportunity to patients.”
The FDA’s decision was eagerly anticipated. Although it was expected that Argenx would receive approval. Argenx is investigating whether efgartigimod can also be used for other autoimmune diseases. Analysts speak of a revenue potential for the drug of USD 5 billion per year in the long term.
The Ghent biotech company also has approval applications pending in Japan and the European Union.
Argenx is listed in the Bel20 star index of the Brussels stock exchange. The biotech company is researching drugs against cancer and serious autoimmune diseases, based on antibodies in the blood of llamas.