Are there any drugs approved by the FDA for COVID-19?

Recently, the FDA cleared several other emergency drugs for COVID-19 in addition to the drug Veklury (remdesivir)

Until recently, there was only one drug approved by the FDA for COVID-19, a type of antiviral drug called Veklury (remdesivir). The FDA approved Veklury on October 22, 2020 for use in adults and certain pediatric patients ages 12 and older, weighing at least 88 pounds, with COVID-19.

Veklury can only be given to patients who are ill enough to require hospitalization, and the use of this medicine is limited to hospitals or other health care facilities where patient care is comparable to hospital care. Veklury is available as a lyophilized powder which is administered intravenously.

The FDA has maintained the Emergency Use Authorization (EUA) of Veklury for use by licensed healthcare providers for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients.

Besides Veklury, the FDA has also cleared several other drugs for emergency use against COVID-19, including certain antiviral drugs and monoclonal antibodies. Recently, the FDA issued an EUA for Pfizer’s drug Paxlovid, which is a combination of two drugs, nirmatrelvir and ritonavir, given as oral tablets. This drug can be used for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older, weighing 88 pounds or more, in the following conditions:

  • Confirmed positive results of 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 initiated as soon as possible after a diagnosis of COVID-19 and within 5 days of onset of symptoms.

What are the side effects of Veklury (remdesivir)?

Side effects of Veklury usually include allergic reactions (hypersensitivity) which may range from mild to severe (anaphylaxis). Veklury can cause liver damage, which is manifested by increased liver enzymes in blood tests.

Hypersensitivity can manifest as:

Does Veklury (remdesivir) prevent COVID-19?

There is no data to date regarding the role of remdesivir in preventing COVID-19. Therefore, the drug is not approved or licensed for the prevention of COVID-19. The only strategies available to prevent COVID-19 are vaccination, social distancing, wearing masks, and practicing hand and respiratory hygiene.

Currently, the monoclonal antibodies tixagevimab and Evusheld (cilgavimab) have been approved by the FDA for the prevention of COVID-19 in certain groups of individuals who are immunocompromised or have a history of severe reactions to a COVD-19 vaccine.

What is an Emergency Use Authorization (EUA)?

EUA refers to the clearance issued by the FDA for emergency use of an unapproved product or unapproved uses of an approved product. In order to issue an EUA, the FDA evaluates several aspects of the products and their use, such as their effectiveness in preventing, diagnosing, or treating a serious or life-threatening medical condition.

An EUA is issued after the FDA has determined that the known and potential benefits outweigh the known and potential risks to the product. In addition, the FDA guarantees that there are no adequate, approved and available alternatives for use in the state of health.

Several drugs have received EUA for the treatment of COVID-19, such as certain antiviral drugs (Paxlovid) and monoclonal antibodies such as bamlanivimab, baricitinib, bamlanivimab and etesevimab, and Casirivimab and Imdevimab.

Medical examination on 1/10/2022

The references

Image source: iStock Images

Comments are closed.