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biotech/news//Newsmax
Japan's Shionogi & Co said on Monday the U.S. Food and Drug Administration has approved its oral antiviral Ensitrelvir.
The FDA approved Shionogi's oral antiviral Xocova for COVID-19 post-exposure prevention.
KEY POINTS
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%.