US regulator approves oral drug from Japan's Shionogi to prevent COVID-19

TOKYO - 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%.

(Reporting by Satoshi Sugiyama; Writing by Kantaro Komiya; Editing by Jan Harvey)

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This story was originally published June 1, 2026 at 10:11 AM.