Recently, in addition to Veklury (remdesivir), the FDA approved several other drugs for use in an emergency with COVID-19.
Until recently, there was only one FDA-approved drug for COVID-19, a type of antiviral drug called Veklury (remdesivir). The FDA approved Veklury for use in adults and certain pediatric patients 12 years and older weighing 88 pounds or more with COVID-19 on October 22, 2020.
Veklury should only be given to patients who are so sick that they need to be hospitalized and the use of this medicine is restricted to hospitals or other health care facilities where patient care is comparable to hospital care. Veklury is available as a lyophilized powder that is given intravenously.
The FDA has continued Veklury’s Emergency Use Authorization (EUA) for use by licensed healthcare providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients.
In addition to Veklury, the FDA has approved several other drugs for use in an emergency against COVID-19, including some antiviral drugs and monoclonal antibodies. The FDA recently issued an EUA for Pfizer’s drug Paxlovid, which is a combination of two drugs – nirmatrelvir and ritonavir – given as oral tablets. This medication can be used to treat mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older who weigh at least 88 pounds in the following cases:
- Confirmed positive results of the direct SARS-CoV-2 test
- High risk of progression to severe COVID-19, including hospitalization or death.
Paxlovid is only available with a prescription. It should be started as soon as possible after the diagnosis of COVID-19 and within 5 days of the onset of symptoms.
What are the side effects of Veklury (Remdesivir)?
The side effects of Veklury generally include allergic (hypersensitivity) reactions that can range from mild to severe (anaphylaxis). Veklury can cause liver damage, which shows up as increased liver enzymes in blood tests.
Hypersensitivity can manifest itself as:
Does Veklury (Remdesivir) Prevent COVID-19?
No data are yet available on the role of remdesivir in preventing COVID-19. Therefore, the drug is not approved or approved for the prevention of COVID-19. The only strategies available to prevent COVID-19 are vaccinations, social distancing, wearing masks, and practicing hand and respiratory hygiene.
Currently, the monoclonal antibodies tixagevimab and Evusheld (cilgavimab) are approved by the FDA for the prevention of COVID-19 in certain groups of immunocompromised people or people with a history of severe reactions to a COVD-19 vaccine.
What is an Emergency Authorization (EUA)?
EUA refers to the FDA-issued approval for the emergency use of an unapproved product or the unapproved use of an approved product. To issue an EEA, the FDA evaluates various aspects of the products and their use, such as their effectiveness in preventing, diagnosing, or treating a life-threatening or serious health condition.
An EEA is issued after the FDA determines that the known and potential benefits outweigh the known and potential risks for the product. In addition, the FDA ensures that there are no adequate, approved and available alternatives for use with health problems.
Several drugs have been given EUAs to treat COVID-19, such as certain antiviral drugs (paxlovid) and monoclonal antibodies such as bamlanivimab, baricitinib, bamlanivimab and etesevimab, as well as casirivimab and imdevimab.
Medically checked on 10.01.2022
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