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        Emergency Preparedness | Drugs

Coronavirus (COVID-19) | Drugs

                        
                Coronavirus Treatment Acceleration Program (CTAP)
          CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 Home
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          Emergency Preparedness | Drugs
          Coronavirus (COVID-19) | DrugsEmergency Preparedness | Drugs Coronavirus (COVID-19) | Drugs
  	
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In response to the novel coronavirus (COVID-19), FDA quickly created, in March 2020, the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biological products (other than vaccines) for COVID-19 therapeutics. The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19. From these efforts, we continue to gain valuable knowledge about the safety and effectiveness of potential therapies for COVID-19.

COVID-19 Therapeutics

What is the difference between FDA approved drugs and drugs authorized under an emergency use authorization (EUA)?
	When FDA approves a drug, it means the agency has determined, among other things, that:

The drug is safe and effective for its intended use;
	The benefits of the drug outweigh its risks when used according to its approved labeling;
	The drug’s labeling (including the package insert) is appropriate; and
	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 FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA.

Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that:

Based on the totality of scientific evidence available-
	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 of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and
	That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition.FDA may revise or revoke EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety.

FDA’s EUA page has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and Response have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s Expiration Dating Extension page.

Learn more about EUAs in this video.
Read more about COVID-19 regulatory terminology on the FDA website.

Types of Treatments (Approved or under EUA)
	**Antiviral Drugs**
	Antiviral drugs are medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body.
	**Immune Modulators**
	Immune modulators are medicines 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.
	**Monoclonal Antibodies (mAbs) targeting SARS-COV-2**
	SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. 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.
	**Renal Replacement Therapy Solutions**
	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.

FDA Approved or Authorized Drugs to Reduce the Risk of Hospitalization or Death for Patients with Mild to Moderate COVID-19
	Paxlovid (nirmatrelvir and ritonavir) is an antiviral drug, approved for certain adults and authorized under EUA for adolescents
	Veklury (remdesivir) in an antiviral drug, approved for certain adults and children
	Lagevrio (molnupiravir) is an antiviral drug, authorized under EUA for certain adults

FDA Approved or Authorized Drugs or Renal Replacement Therapy Solutions to Treat or Support Patients Hospitalized Due to COVID-19
	Actemra (tocilizumab) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children
	Olumiant (baricitinib) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children
	Veklury (remdesivir) is an antiviral drug, approved for certain adults and certain infants and children)
	Kineret (anakinra) is an immune modulator drug, authorized under EUA for certain adults
	Gohibic (vilobelimab) is an immune modulator drug, authorized under EUA for certain adults
	Regiocit replacement solution is a renal replacement therapy solution, authorized under EUA for certain adults
	Fresenius Medical multiFiltrate/multiBic/multiPlus replacement solutions are renal replacement therapy solutions, authorized under EUA for certain adults

Other Resources
	Know Your Treatment Options for COVID-19
	Emergency Use Authorizations for Drugs
	CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
	COVID-19 Therapeutics Expiration Dating Extensions
	Coronavirus Treatment Acceleration Program (CTAP)
	Revoked EUAs for COVID-19
	Coronavirus (COVID-19) | CBER-Regulated Biologics
	At-Home OTC COVID-19 Diagnostic Tests
	FDA Coronavirus Disease 2019 (COVID-19)
	What Happens to EUAs when a public health emergency ends?
	USG COVID-19 Home Page
Sub-Topic Paragraphs
          Additional ResourcesCoronavirus Treatment Acceleration Program (CTAP)
            Acceleration of development for COVID-19 treatments
          Additional ResourcesCOVID-19 Treatment Hub
            Provides physicians, patients, and caregivers with information about the latest research in the fight against COVID-19COVID-19 Test to Treat Locator
            Faster, Easier Access to Life‐Saving COVID‐19 TreatmentsCOVID-19 Real World Data (RWD) Data Elements Harmonization Project
            Mapping spreadsheet of COVID-19 data elements to several Common Data Models (CDMs) and open standardsFDA Sentinel System’s Coronavirus (COVID-19) Activities
            Monitors the use of drugs, describes the course of illness among hospitalized patients, and evaluates therapies
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                                                                                  Content current as of:
      12/29/2023
                  
                   
Regulated Product(s)
		 DrugsHealth Topic(s)
			  Infectious Disease
			    			       			    			       CoronavirusCoronavirus (COVID-19) | Drugs                
                          

                        Coronavirus Treatment Acceleration Program (CTAP)
          CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
 
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