Shots:
- The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU
- NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure prophylaxis for COVID-19 across Asia
- Trial showed sustained Omicron-related symptoms resolution for ≥24hrs. (1EP) & antiviral efficacy (2EP) in mostly vaccinated mild-to-mod. COVID-19 pts, regardless of risk factors; data published in The JAMA Network Open
Ref: Shionogi | Image: Shionogi | Press Release
Related News:- BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate
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