argenx SE (NASDAQ: ARGX) confirmed that VYVGART has obtained the authorization of Japan’s Ministry of Health, Labour, and Welfare (MHLW) for the cure of adult patients with generalized myasthenia gravis (gMG). VYVGART become the first-and-only neonatal Fc receptor (FcRn) blocker authorized in Japan.
The authorization of VYVGART is based on results from the global Phase III ADAPT study, which was released in the July 2021 issue of The Lancet Neurology. The ADAPT study fulfilled its primary endpoints. The study highlights that more anti-acetylcholine receptor (AChR) antibody-positive gMG sufferers were responders on the myasthenia gravis activities of daily living (MG-ADL) scale after cure with VYVGART compared with placebo.
Furthermore, argenx stated that its commercial teams are prepared and eager to help as many individuals as possible who are suffering from this terrible illness. It is looking forward to working with the Japanese government to make patient access a reality. With today’s authorization in Japan, the recent FDA clearance in the United States, and the ongoing review of its application in Europe, it will keep making rapid progress toward its objective of bringing this unique, targeted therapy option to the world.
In addition, in the ADAPT clinical trial, VYVGART showed a proven safety profile. Respiratory tract infection, headache, and urinary tract infection were the most prevalent side events in ADAPT. Moreover, on December 17, 2021, the US FDA authorized VYVGART for the therapy of gMG in elderly patients who are AChR antibody positive.
The EMA is now reviewing a Marketing Authorization Application for efgartigimod for the therapy of gMG. Moreover, the decision is likely to come in the second half of 2022. Furthermore, Argenx is now testing efgartigimod in six high-need autoimmune diseases, with plans to extend to ten by the end of 2022.