Posted by Michael Wonder on 04 Apr 2023
Shionogi receives US FDA fast track designation for ensitrelvir fumaric acid, an investigational oral anti-viral for COVID-19
4 April 2023 - Shionogi today announced that the US FDA has granted fast track designation for their investigational COVID-19 oral anti-viral ensitrelvir (ensitrelvir fumaric acid, Code No.: S-217622)
Ensitrelvir, known as Xocova 125 mg tablets in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare for the treatment of SARS-CoV-2 infection. It remains an investigational drug outside Japan.
