| The FDA is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic. For CDER, these efforts include accelerating development of treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to stakeholders, advising developers on how to handle clinical trial issues and keeping the public informed. Information on some of CDER's efforts related specifically to drugs and COVID-19 can be found in the 2020 and the 2021 issues of the newsletter (click here to access the 2020 and 2021 issues) and at the webpages below: Some recent updates are provided below: COVID-19 APPROVALS. EMERGENCY USE AUTHORIZATIONS AND UPDATES FDA Approves First COVID-19 Treatment for Young Children April 25, 2022: The FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. Read more here. FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals December 3, 2021: The FDA issued an emergency use authorization (EUA) for AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). Read more here. FDA Authorizes First Oral Antiviral for Treatment of COVID-19 December 22, 2021: The FDA issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Read more here. FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults December 23, 2021: The FDA issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Read more here. FDA Authorizes New Monoclonal Antibody, Bebtelovimab, for Treatment of COVID-19 That Retains Activity Against Omicron Variant February 11, 2022: The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-Cov-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. Read more here. FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns December 3, 2021: The FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab administered together (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, with positive results of direct SARS-Cov-2 viral testing and are at high risk for progression to severe COVID-19, including hospitalization or death. Read more here. FDA Expands Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 January 21, 2022: The FDA has expanded the approved indication for Veklury(remdesivir) to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. The agency also revised the Emergency Use Authorization (EUA) for Veklury to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization of death. Read more here. FDA updates the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1). December 23, 2021: The data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant. Read more here. FDA updates Sotrovimab Emergency Use Authorization February 25, 2022: FDA revised the emergency use authorization for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. Read more here. April 5, 2022: Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Read more here. FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant January 24, 2021: Based on the most recent information and data available, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Read more here. | 
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