The Center for Drug Evaluation and Research (CDER) is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic.
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.
Veklury (Remdesivir) is an antiviral drug approved for use in adults and pediatric patients [12 years of age and older and weighing at least 40 kilograms (about 88 pounds)] for the treatment of COVID-19 requiring hospitalization.
All therapeutic products authorized under an EUA are listed on the FDA’s EUA page.
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. The following SARS-COV-2-targeting mAbs are authorized for use through an EUA for the treatment of certain patients with COVID-19.
On June 25, 2021, the HHS Assistant Secretary for Preparedness and Response (ASPR) issued a nationwide pause on the distribution of bamlanivimab and etesevimab.
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 certain pediatric patients, specifically for use in pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
While not FDA-approved, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. For additional information on the authorized use of Veklury under the EUA, refer to the Fact Sheet for Healthcare Providers.
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.
FDA issued an EUA for baricitinib (Olumiant), an immune modulator, in combination with remdesivir (Veklury) for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older and requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO).
FDA issued an EUA for Actemra (Tocilizumab), a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor, for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Actemra does not directly target SARS-COV-2. Actemra is FDA-approved for the treatment of multiple inflammatory diseases, including rheumatoid arthritis. Actemra is not FDA-approved as a treatment for COVID-19.
Sedatives are drugs that maintain sedation, generally via continuous intravenous infusion, in patients who are intubated and require mechanical ventilation in an intensive care unit (ICU) setting. The following sedatives are authorized for emergency use:
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.
The following renal replacement therapies are authorized for use:
- Regiocit replacement solution
- Fresenius Medical multiFiltrate/multiBic/multiPlus replacement solutions
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