FDA approves first oral antiviral for treatment of COVID-19 in adults

Public health emergency response and other updates from FDA since our last MCMi email include:

• May 30, 2023: FDA Roundup including a final guidance describing the agency’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug and biological product development programs - also see the Guidance Snapshot (PDF)
• May 30, 2023: FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information
• May 26, 2023: FDA Roundup including continuing reports of adverse events that were associated with use of EzriCare Artificial Tears and Delsam Pharma’s Artificial Eye Ointment, which were previously recalled due to potential bacterial contamination
• May 25, 2023: FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

Paxlovid manufactured and packaged under the EUA (PDF) and distributed by HHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. (May 25, 2023)

Also see these updated resources (PDFs):

• Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers
• Frequently Asked Questions on the EUA for Paxlovid for Treatment of COVID-19
• Fact Sheet for Healthcare Providers: EUA for Paxlovid
• Approved product label (new)

EUA revocations

FDA revoked the following EUAs for the reasons noted in the revocation letters (PDFs): 

• May 24, 2023: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay (NeuMoDx Molecular, Inc., a QIAGEN Company) 
• May 24, 2023: VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System (Becton, Dickinson and Company)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.