默沙东口服新冠药Molnupiravir FDA审评信息.pdfVIP

FDA Introductory Remarks Antimicrobial Drugs Advisory Committee Meeting November 30, 2021 John Farley, MD, MPH Director Office of Infectious Diseases Center for Drug Evaluation and Research Introduction • Molnupiravir (MOV, MK-4482) is an oral prodrug of the antiviral ribonucleoside analog N-hydroxycytidine (NHC). MOV inhibits viral replication by causing an accumulation of errors in the viral genome leading to inhibition of replication. • The sponsor, Merck Co., Inc., has submitted a request for Emergency Use Authorization (EUA) of MOV. The emergency use under consideration is: treatment of mild-to-moderate COVID-19 in adults with a positive result of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. • The proposed oral dosage regimen is 800 mg (4 - 200 mg capsules) every 12 hours for 5 days. 2 Eligibility of MOV for EUA • The FDA EUA authority to authorize an unapproved product or unapproved uses of an approved product for emergency use exists during a public health emergency after a declaration by the Secretary of the Department of Health and Human Services. • The Secretary has determined1 that a public health emergency exists that involves the virus, SARS-CoV-2, that causes COVID-19, and declared circumstances exists justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic2. • Based on this declaration, FDA may issue an EUA after determining statutory requirements are met. 1pursuant to Section 564(b)(1)(C) of the Federal Food, Drug Cosmetic Act (FDC Act) 2pursuant