Shionogi Seeks Japan Approval of S-268019 for the Treatment of COVID-19


The company had filed for approval in Japan of S-268019 for use in priming and booster (3rd) doses against COVID-19. The filing was based on the positive results of five clinical trials
The 1EPs of the P-III trial for the priming dose were met which showed superiority by comparing GMT of SARS-CoV-2 neutralizing Ab titer @28 days, after the 2nd vaccination of S-268019 over ChAdOx1 nCoV-19
The 1EPs for the booster dose (3rd dose) study was also met which demonstrated non-inferiority of the S-268019 over Comirnaty when the GMT & seroresponse rate of the SARS-CoV-2 neutralizing Ab titer were compared which was measured on the 29th day (28 days after inoculation), no major clinical concerns were reported on in any of the 5 trials

Ref: Shionogi | Image: Shionogi