Remdesivir FAQ

1. Is remdesivir approved by the FDA to treat COVID-19?
 

No. Remdesivir is an investigational antiviral drug. It is not currently FDA-approved medication to treat or prevent any diseases, including COVID-19. 

But the EUA (Emergency Use Authorization) allows remdesivir, manufactured by Gilead, to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. 

Severe COVID-19 is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO), a heart-lung bypass machine.

2. Whats the data showing remdesivir might benefit patients with COVID-19?
 

In vitro (laboratory) testing of remdesivir demonstrated it is active against SARS-CoV-2 (the virus causing COVID-19). Preliminary results from a Phase 3, placebo-controlled clinical trial of remdesivir by the National Institute for Allergy and Infectious Diseases suggested that patients taking remdesivir experienced faster time to recovery as compared to patients taking a placebo. This trial included a sizeable proportion of patients who were receiving mechanical ventilation or extra corporeal membrane oxygenation (ECMO) at baseline. Based on above findings, the Fact Sheet for Health Care Providers details a 10-day treatment course for patients receiving mechanical ventilation or ECMO.  Preliminary results from a different Phase 3 trial evaluating 5-day and 10-day dosing duration of remdesivir in hospitalized patients with severe COVID-19 disease reported that patients receiving a 5-day treatment course achieved similar improvement as those taking a 10-day treatment course; however, importantly, very few patients in this trial were receiving mechanical ventilation or ECMO at baseline.  Therefore, based on these findings, the Fact Sheet for Health Care Providers details a 5-day treatment course for patients who are not receiving mechanical ventilation or ECMO. 

Patients who receive a 5-day treatment course but do not demonstrate clinical improvement are eligible to continue to receive remdesivir for an additional 5 days. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing clinical trials. Because remdesivir may possibly help very sick patients, FDA is allowing this drug to be provided to hospitalized patients with severe COVID-19 under an EUA issued May 1, 2020. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. However, final data from clinical trials included in an FDA application are necessary for us to determine whether the drug is safe and effective in treating or preventing COVID-19.

3. What are the possible side effects of remdesivir?
 

Possible side effects of remdesivir are: 

(a) Infusion-related reactions. Infusion-related reactions have been seen during a remdesivir infusion or around the time remdesivir was given. Signs and symptoms of infusion-related reactions may include: low blood pressure, nausea, vomiting, sweating, and shivering.
 

(b)Increases in levels of liver enzymes, seen in abnormal liver blood tests. Increases in levels of liver enzymes have been seen in people who have received remdesivir, which may be a sign of inflammation or damage to cells in the liver.
These are not all the possible side effects of remdesivir. Remdesivir is still being studied so it is possible that all of the risks are not known at this time.

4.How does this EUA add to/differ from the existing Expanded Access approval? 

An EUA is a temporary measure, pursuant to a Secretary of Health and Human Services declaration, in which the FDA Commissioner may authorize unapproved medical products or unapproved uses of approved medical products for use in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear (CBRN) threat agents. 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 the CBRN 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.

On May 1, 2020, FDA granted Gilead’s EUA request allowing remdesivir to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. For the purposes of this EUA, severe COVID-19 is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, mechanical ventilation, extra corporeal membrane oxygenation (ECMO), or a heart-lung bypass machine. FDA’s EUA for remdesivir is limited in scope and subject to the conditions as detailed in the letter of authorization. While EUAs may only be issued while the Secretary of Health and Human Services declaration justifying emergency use is in effect, requests for expanded access to an investigational drug may be submitted to FDA and considered at any time. Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access requires submission of an expanded access protocol to an existing investigational new drug application (IND) or a new expanded access IND, and is subject to certain IND requirements, such as IND safety reporting and informed consent.   For remdesivir, the following mechanisms may be available for expanded access:
Treatment under emergency investigational new drug applications (EINDs) for pregnant women and children less than 18 years of age with confirmed COVID-19 or severe manifestations of disease if they cannot gain access to remdesivir via the EUA.For more information about expanded access to remdesivir.

5. What if patient is given first hydroxychloroquine sulfate for a chronic condition? Does this mean that patient should not be given remdesivir?

 There is the potential for remdesivir to not work as well to treat severe COVID-19 when it is taken with hydroxychloroquine sulfate (HCQ) or chloroquine phosphate (CQ). FDA recommends against taking the drugs together. If you are taking  HCQ or CQ, discuss your options andspecific situation with your health care provider.

 

6. Is remdesivir approved for use in pediatric patients?

 

A 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. remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. For additional information on the approved uses, refer to the Prescribing Information. 

While not FDA-approved, the Emergency Use Authorization (EUA)  for remdesivir continues to authorize remdesivir 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 remdesivir under the EUA, refer to the Fact Sheet for Healthcare Providers.