# Japan's Shionogi & ‌Co said on Monday the U.S. Food and Drug Administration has approved its oral antiviral Ensitrelvir.

*biotech · news · 2026-06-02 · Newsmax*

## Key points

- The FDA approved Shionogi's oral antiviral Xocova for COVID-19 post-exposure prevention.
- Xocova is the first oral medication proven to prevent symptomatic COVID-19 after exposure.
- Xocova's effectiveness applies regardless of participants' vaccination status.
- Shionogi's financial forecasts already account for Xocova's FDA approval impact before March 2027.

Japan's Shionogi & ‌Co said on Monday the U.S. Food and Drug Administration has approved its oral antiviral Ensitrelvir, commercially ‌known as Xocova, for ​the preventive treatment of individuals who have been ⁠exposed to COVID-19. "XOCOVA is ​the first and only oral ⁠option clinically proven to help prevent symptomatic COVID-19 after exposure among ‌study participants regardless of ​vaccination status," Nathan McCutcheon, ‌CEO of Shionogi's U.S. unit, ‌said in a statement. The financial impact of the FDA ⁠approval of ‌Xocova in ⁠the current fiscal year ending March ⁠2027 ⁠has already been reflected in the earnings ‌forecast announced last month, Shionogi said. Shionogi shares were down ‌4.5% ​on Monday, ‌while the benchmark Nikkei 225 index was up 0.9%.

**Companies:** Shionogi & Co
**Countries:** Japan, United States

[Read the full story on Newsmax](https://www.newsmax.com/health/health-news/covid-fda-oral/2026/06/02/id/1258245/)

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