Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japan­ese reg­u­la­tors on Tues­day signed off on Sh­iono­gi’s home­grown an­tivi­ral for Covid-19, known as Xo­co­va (en­sitrelvir), mak­ing it the first ap­proval un­der Japan’s emer­gency reg­u­la­to­ry ap­proval sys­tem.

The emer­gency ap­proval, fol­low­ing a back-and-forth with reg­u­la­tors since last Feb­ru­ary, is based on a safe­ty pro­file with more than 2,000 pa­tients who have ac­cessed the pill, and clin­i­cal symp­to­matic ef­fi­ca­cy for five typ­i­cal Omi­cron-re­lat­ed symp­toms (pri­ma­ry end­point) and an­tivi­ral ef­fi­ca­cy (key sec­ondary end­point) in pa­tients with mild to mod­er­ate SARS-CoV-2 in­fec­tion, re­gard­less of risk fac­tors or vac­ci­na­tion sta­tus, and dur­ing the Omi­cron-dom­i­nant phase of the pan­dem­ic.

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