Shionogi Seeks Japan Approval of S-268019 for the Treatment of COVID-19
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
