Japan’s Shionogi & Co has received approval from the U.S. Food and Drug Administration (FDA) for its oral antiviral Ensitrelvir, marketed as Xocova, as a preventive treatment for people who have been exposed to COVID-19.
The decision makes Xocova the first FDA‑approved oral option shown in clinical trials to help prevent symptomatic COVID-19 after exposure, regardless of a person’s vaccination status.
The drug is designed to be taken after close contact with an infected individual, aiming to reduce the risk of developing symptoms and to ease pressure on health systems that still face periodic waves of infection. Shionogi said late-stage studies demonstrated that Xocova significantly lowered the incidence of symptomatic COVID-19 compared with placebo, supporting its role as a post‑exposure prophylaxis option alongside vaccination and other public health measures.
Xocova has already been used in Japan, where it first received emergency authorisation in 2022 before gaining full approval in 2024 as a treatment for COVID-19, and the U.S. decision is expected to expand its global footprint and commercial potential. Company executives said the approval marks an important step in building a broader COVID-19 product portfolio and offers an additional tool to protect high‑risk groups, including older adults and people with underlying conditions, when cases surge.
