FDA Approves Japanese Company’s Oral COVID Prevention Drug

A Japanese pharmaceutical company announced Monday that federal health regulators have given the green light to its oral medication designed to prevent COVID-19 in people who have been exposed to the virus.

Shionogi & Co said the Food and Drug Administration has approved Ensitrelvir, which goes by the brand name Xocova, for preventive treatment following COVID exposure.

“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 company indicated that potential revenue from the FDA’s approval of Xocova through March 2027 was already factored into financial projections released last month.

Stock prices for Shionogi dropped 4.5% on Monday, even as Japan’s main stock index, the Nikkei 225, climbed 0.9%.