FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. Although the PHE will expire, the COVID-19 pandemic remains a high priority for the Center for Drug Evaluation and Research (CDER). CDER will remain engaged with numerous activities to protect and promote public health.
The ending of the COVID-19 PHE will not impact CDER's ability to authorize treatments for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so.
Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), the FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services, authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the EUA.
FDA approves new drug applications (NDAs) under section 505(c) of the FD&C Act and biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act). In approving an NDA/BLA, FDA reviewers must determine, among other things, that the drug is safe and effective for its labeled use(s), and that the benefits of the drug outweigh the risks; that the drug's labeling (package insert) is appropriate; and that the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. The statutory standard for an NDA/BLA approval requires substantial evidence of effectiveness, which is a higher level of evidence of effectiveness than required for an EUA.
Actemra (Tocilizumab) is approved for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Veklury (Remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) 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.
- Health care Provider Preparation and Storage Information (PDF - 359 KB)
Olumiant (baricitinib) is approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Paxlovid (nirmatrelvir and ritonavir) is approved 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 not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
CDER’s EUA page lists all therapeutic products currently authorized under an EUA, as well as the current product Fact Sheets and additional information for health care providers and patients.
FDA and HHS/ASPR have announced extensions to the shelf life for some EUA products. These updates can be found on FDA’s Expiration Dating Extension page.
Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body.
As noted above, Veklury (remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) 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.
Immune modulators are a category of drugs that help activate, boost, or suppress the immune function. In the case of COVID-19 infection, the immune system can become hyperactive which may result in worsening of disease. Immune modulators can help suppress this hyperinflammation.
- Kineret (anakinra) is authorized for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
- Olumiant (baricitinib) is authorized for the treatment of COVID-19 in pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO).
- Actemra (tocilizumab) is authorized for the treatment of COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Gohibic (vilobelimab) is authorized for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
As noted above, Olumiant (baricitinib) is approved for the same indication for hospitalized adult patients.
SARS-COV-2-targeting Monoclonal Antibodies
SARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry into human cells, thus neutralizing the virus like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. Due to the high frequency of variants circulating within the United States that are not susceptible to the following mAbs, the products below are not currently authorized in any U.S. region until further notice by FDA and may not be administered for the pre-exposure prophylaxis for prevention or the treatment of COVID-19 under the EUA:
- REGEN-COV (casirivimab and imdevimab)
- Bamlanivimab and Etesevimab
- Evusheld (tixagevimab co-packaged with cilgavimab)
Renal Replacement Therapies
Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a machine treatment that filters and purifies the blood when a patient’s kidneys are damaged or are not functioning normally. CRRT is used for patients with kidney injury in acute care settings.
SARS-CoV-2 led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. In addition, there was an insufficient supply of replacement solutions to meet the emergency need to provide CRRT in critically ill patients.
- Regiocit replacement solution
- Fresenius Medical multiFiltrate/multiBic/multiPlus replacement solutions
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