FDA to Review Ensitrelvir as Potential COVID-19 Preventative
Washington, D.C. - The Food and Drug Administration (FDA) will review ensitrelvir, an oral antiviral drug developed by Shionogi & Co., Ltd., for use in preventing COVID-19, the agency announced today. The review will focus on data submitted in a New Drug Request (NDA) seeking approval for the prophylactic use of the medication.
This potential preventative treatment arrives as public health officials continue to monitor evolving variants and seek strategies to mitigate the ongoing impact of COVID-19, especially for vulnerable populations. If approved, ensitrelvir could offer a new layer of protection against infection, complementing existing vaccines and treatments. The FDA’s review process will assess the drug’s safety and efficacy in preventing COVID-19, with a decision expected in the coming months.Ensuring a proactive defense against COVID-19 remains a priority, and the FDA’s review of ensitrelvir represents a significant step in expanding the toolkit available to combat the virus. Shionogi initially reported positive Phase 3 trial results in Japan earlier this year, demonstrating a ample reduction in the risk of symptomatic COVID-19 infection among household contacts of infected individuals. The NDA submission includes data from these trials,providing the FDA with a comprehensive evaluation of the drug’s potential benefits.
The review will determine if ensitrelvir meets the agency’s rigorous standards for safety and effectiveness before perhaps becoming available to the public. The FDA has not announced a specific timeline for its decision, but will likely convene an advisory committee to discuss the data before making a final determination.
