The First Drug Has Been Officially Approved by the FDA for COVID-19

COVID-19, medicare, remdesivir, Gilead

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The first drug for COVID-19 has been officially approved by the FDA. Remdesivir is approved for hospitalized patients ages 12 and up weighing at least 88 pounds. While it’s not a cure, the antiviral drug remdesivir has been shown to reduce hospital stays in older adults.

Remdesivir, which Gilead is calling Veklury, is administered by an IV for hospitalized patients. It has been shown to reduce recovery time by 5 full days, according to a study by the U.S. National Institutes of Health. 

Since May, doctors have been using the drug for COVID-19 in emergency settings under emergency use authorization. In August, the FDA began allowing its use in non-emergency cases as well. Now, the drug has officially gained FDA approval. 

Controversy surrounding the drug 

Even so, the evidence doesn’t seem to be 100% in remdesivir’s favor. A study from the World Health Organization showed that the drug did not affect whether one died from COVID-19. Experts also warn that the approval of remdesivir could undermine further research on treatments that could work better. Now, clinical trials of new drugs will have to be compared against remdesivir and a placebo. 

The cost of the drug has also raised some concerns. Remdesivir costs $3,120 for a five-day course of IV treatment for those with private insurance, and $2,340 for those covered by government health programs like Medicare. Gilead is likely to make around $2.3 billion in profits off remdesivir in 2020 alone.

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What is remdesivir? 

Remdesivir is an intravenous (administered into the veins) antiviral drug that was once studied for Ebola, then used for SARS and MERS.

Remdesivir is not a cure for the coronavirus, but an experimental drug that may speed up recovery. It is currently the most successful drug for the virus globally. 

How does it work?

Once SARS-CoV-2, invades a human cell, it replicates with the help of a viral enzyme called RdRp. Remdesivir is designed to slow or stop the virus from cloning itself by blocking this particular enzyme.

The drug works differently than antibody-based treatments or vaccines, which are designed to help a person’s immune system identify and eliminate pathogens.

Remdesivir is most effective when administered as soon as a patient begins to show symptoms. The challenge is that the drug is administered to the patient for five to 10 days through an IV.

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, suggested that remdesivir could reduce recovery time by a median of four to 11 days compared with 15 days for those who got a placebo.

What are the side effects of remdesivir?

The drug is not to be used in conjunction with hydroxychloroquine, which can reduce its effectiveness. Possible side effects include heightened liver enzymes, fever, shortness of breath, low blood oxygen level, wheezing, rash, nausea, sweating, or shivering.

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