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FDA endorses Remdesivir in extreme cases

We find ourselves in an unprecedented time as social distancing has taken full effect throughout most of the country. Some cities/states are beginning to ease their restrictions, but is it far too early to begin this process? There are no Food and Drug administration (FDA) approved vaccinations or treatments for COVID-19 and there are hotspots across the country where cases of the virus are still high. Do cities and states run the risk of creating an even bigger outbreak if we open up too early? As of May 4th, the New York City (NYC) Department of Health reported over 170,000 cases of COVID-19 with 43,000 hospitalizations and 13,000 fatalities. The FDA is working closely alongside pharmaceutical companies and top Universities both nationally and worldwide. Several drugs are being evaluated for efficacy, but due to a lack of data the FDA neither recommends for or against any treatment for COVID-19.

Remdesivir

The most recent drug on the FDAs radar is Remdesivir. Dr. Anthony Fauci; director of  the National Institute for Allergies and Infectious Disease (NIAID) made the announcement regarding the use of Remdesivir for COVID-19 treatment. Remdesivir is an antiviral compound initially developed by Gilead Sciences during the 2014-2016  Ebola Outbreak. Gilead tested Remdesivir in animal and cell models against MERS and SARS, other members of the coronavirus family and related to COVID-19.


Worldwide there are 6 ongoing clinical trials, three in the United States headed by Gilead and NIAID, while the remaining 3 are in China and France. Gilead has two ongoing trials focused on  patients with moderate infection and severe infection and has the highest concentration of enrollment sites in New York, New Jersey, Massachusetts, Texas and Washington State. The results of these trials are pending.

Thus far the NIAID Trial has shown promising results. Patients who received Remdesivir on average recovered in 11 days compared to 15 days for those who did not receive the treatment (31% improvement in recovery time). Patients who received Remdesivir also had a decreased mortality rate of 8% as opposed to 11% in the placebo group (no treatment). Due to the severity of the pandemic, the FDA has allowed use of this drug in extreme cases and under compassionate care. At this point in time, a substantial amount of evidence is required for the FDA to decide to approve Remdesivir as a treatment choice nationwide.

Chloroquine/Hydroxychloroquine

Another drug which has received an immense amount of attention is Chloroquine. Chloroquine is an FDA approved treatment and prevention method for Malaria. Another form of the drug known as Hydroxychloroquine is an FDA approved treatment for Rheumatoid Arthritis and Lupus. During the initial weeks of the COVID-19 outbreak, Chloroquine began receiving a lot of attention from the FDA and medical providers. In terms of drug development, it is much easier to receive FDA approval for a treatment method if it is already FDA approved for another indication. Because Malaria is also a virus, it was assumed that Chloroquine could be a viable treatment option.

The FDA recently announced that they do not recommend the use of Chloroquine in COVID-19 patients in non-emergency settings. This means that patients should only receive this drug in severe circumstances during a hospitalization. This recommendation was due to the possibility of inducing a dangerous abnormal heart rhythm in patients who also received Azithromycin; a commonly used antibiotic.  It’s important to note that this does not mean Chloroquine won’t eventually become an FDA approved treatment. This means that the FDA currently only wants patients taking this drug for treatment of COVID-19 unless they are currently hospitalized or enrolled in a clinical trial. There are currently dozens of ongoing clinical trials investigating the efficacy and safety of numerous therapies. While there are no FDA approved treatments, it appears the FDA is willing to work with pharmaceutical companies to fast-track clinical trials in order to bring the best treatment options to market as quickly as possible. On average it can take anywhere from 10-15 years to bring a drug to market , with the help of the FDA this time can be drastically decreased to help bring normalcy back to society.