FDA gives East Flemish firm all clear to launch myasthenia gravis drug in the US
A drug for the treatment of the rare neuromuscular disease myasthenia gravis that has been developed by the Ghent biotech company Argenx has by approved for sale in the United States by the Food and Drug Administration (FDA). Analysists say that Efgartigimod that will be sold under the brand name Vyvgart has the potential to earn Argenx billions of euro.
The FDA approved Vyvgart for use as an orphan drug. The Head of Neuroscience at the FDA Billy Dunn said that “There are considerable unfulfilled medical needs for people living with myasthenia gravis. Today’s approval is an important step towards being able to offer new therapeutic possibilities to patients”.
The FDA’s approval had been eagerly awaited, although the expectation had been that Argenx would receive the all-clear from US Food and Drug Administration. Argenx is now looking into whether Efgartigimod can be used for treatment of other auto-immune diseases.
Some analysts believes that it could produce a potential turnover of as much as 5 billion dollars per annum. The Ghent biotech company is currently awaiting the approval of the EMA and the Japanese authorities for the use of Efgartigimod in the EU and Japan.