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Remdesivir FDA Approved for Hospitalized COVID-19

Oct 22, 2020 6:09 pm

The FDA has approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

FDA approved its 1st drug to treat COVID-19 - the antiviral drug Veklury (remdesivir) for for acute care treatment of COVID-19 requiring hospitalization. Approval was based on 3 clinical trials showing clinical improvement, but no change in mortality rates.

Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. 

While there are 3 trials demonstrating the efficacy of IV remdesivir, the data from the large WHO sponsored, Solidarity trial, showed no benefit when remdesivir was used in COVID-19 patients.  Remdesivir was originally developed as an antiviral drug for hepatitis C, but failed to find success with multiple viral infections, including SARS, MERS and Ebola. Gilead has suggested the WHO study was biased by not being “blinded”.

Remdesivir (brand name Veklury) will cost $3,120 for a five-day treatment course. 

 

Disclosures
The author has no conflicts of interest to disclose related to this subject

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