Key takeaways:

The FDA accepted a new drug application for the oral antiviral ensitrelvir to be used as COVID-19 post-exposure prophylaxis.

A study showed it reduced the risk for household spread of SARS-CoV-2 by 67%.

The FDA on Tuesday accepted a new drug application from Shionogi to market ensitrelvir, an oral antiviral, as post-exposure prophylaxis for COVID-19, the company announced.

The agency set a date of June 16, 2026, to make a decision on whether to approve the medication for COVID-19 prevention among people who have been exposed to someone with the illness.

The announcement comes during an uncertain time for COVID-19 prevention, which has been upended by changing approvals and recommendations .

Healio | Infectious Disease News Editorial Board Member William Schaffner,

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