Shionogi said on September 3 that the US FDA has accepted for review its new drug application for the oral antiviral agent ensitrelvir, approved as Xocova in Japan, for the indication of post-exposure prophylaxis of COVID-19.

FDA Accepts Xocova NDA for COVID Post-Exposure Prophylaxis

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Ensitrelvir, also known as Xocova, is already approved for use in Japan.

New antiviral application for COVID-19 preventive drug submitted to FDA

Shionogi &amp; Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Shionogi Inc., a New Jersey-based subsidiary of Shionogi, for ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622).

FDA Accepts Shionogi’s Ensitrelvir NDA as the First Oral Therapy for the Prevention of COVID-19 Following Exposure

Patients receiving nirmatrelvir/ritonavir experience a quicker resolution of COVID-19 symptoms and are less likely to have worsened symptoms than those receiving placebo, a recent study shows.

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