Business
FDA Accepts Shionogi’s Ensitrelvir NDA as the First Oral Therapy for the Prevention of COVID-19 Following Exposure
OSAKA, Japan, September 02, 2025--Shionogi & 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), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual.
About this update from Shionogi & Co., Ltd.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":385,"height":480,"url":"https://media.zenfs.com/en/business-wire.com/0d29376ca7f68abf947c292c00286ecf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/HhQMgQ_zWXk1gN2xwoeVIQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTg3OTtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/0d29376ca7f68abf947c292c00286ecf","width":385,"height":480}},"lazy":false},{"type":"text","content":"Application is based on results from SCORPIO-PEP, the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual*","length":201,"tagName":"p","attribs":{}},{"type":"text","content":"OSAKA, Japan, September 02, 2025--(BUSINESS WIRE)--Shionogi & 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), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual. The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA).","length":629,"tagName":"p"},{"type":"text","content":"The NDA is supported by results from the global, double-blind, randomized, placebo-controlled Phase 3 Study, SCORPIO-PEP, which studied ensitrelvir as post-exposure prophylaxis (PEP). If approved, ensitrelvir would be the first and only oral therapy for the prevention of COVID-19 following exposure to an infected individual.1,2","length":329,"tagName":"p"},{"type":"text","content":"SARS-CoV-2 remains highly transmissible and up to half of people living with an infected individual may develop COVID-19.3,4 The virus is constantly evolving, with novel symptoms reported.5,6 COVID-19 continues to impact daily life and may lead to absence from school and work, may cause long COVID, and in some cases, may progress to severe disease.7-12 Even patients with mild COVID-19 may experience worsening of preexisting chronic conditions.13-17","length":452,"tagName":"p"},{"type":"text","content":"Following exposu...