Categories: General NewsHealth

US Authorizes Use of Anti-Viral Drug Remdesivir for the Treatment of COVID-19

Emergency use of the Ebola drug, Remdesivir, was authorized by the US Food and Drug Administration (FDA), for the treatment of the coronavirus.

This authorization implies that the anti-viral drug can now be used legally, on patients that are hospitalized with severe symptoms of COVID-19. The drug has shown to help shorten the time taken by patients who are severely ill, to recover, according to a recent clinical trial. However, survival rates were not significantly improved.

The drug has been warned, by experts, that its original development was for the treatment of Ebola, and is produced by Gilead pharmaceutical company in California. Hence, experts say, that it should not be seen as a magic cure for the COVID-19. The drug interferes with the genome of the virus, which in turn disrupts its ability to replicate.

A meeting was held with the US President Donald Trump, in the Oval Office, where Gilead Chief Executive Daniel O’Day has reportedly said that the FDA authorization was an incredibly essential first step. He added that the company is to donate 1.5 million vials of the promising drug.

FDA Commissioner Stephen Hahn was also present at the meeting and had reportedly said that, this is officially the first authorized therapy for COVID-19, and that they were proud to be a part of it. However, formal approval requires a higher level of review and is hence not the same as an emergency FDA authorization.

Remdesivir did not cure Ebola. According to Gilead on his website, the drug is an experimental medication with no established safety or efficacy, regarding the treatment of any condition whatsoever, and goes on to warn about the potential side effects. On the contrary, President Trump has shown incredible support by becoming a vocal supporter of Remdesivir as a potential treatment for the COVID-19.

A clinical trial by the US National Institue of Allergy and Infectious Diseases (NIAID) whose full results are yet to be released, it was found that the drug had shortened the duration of symptoms from 15 days, to 11 days.

1,063 people at hospitals worldwide – including the US, France, Italy, the UK, China, and South Korea, were involved in the trials, where some patients were given a placebo treatment and others were given the drug.

According to Dr. Anthony Fauci who runs NIAID, the drug had a clear and significant effect in the diminishing of recovery time. However, despite the drug’s aid in recovery, and potentially stopping patients from having to be treated in intensive care, no clear indication was given in the trials regarding its prevention of COVID-19 death.

Despite the ambiguity about the treatment regime, Gilead has suggested a 10-day dosing duration for infected patients on ventilators, and 5-day dosing for infected patients that are not. The FDA’s jurisdiction is not stretching overseas and only applied to the US, with experts suggesting that the emergency use and full approval are not the same.

According to Gilead, existing stocks of the drug are being used, with the limitations in the supply, because of which the US government will co-ordinate the distribution of Remdesivir to hospitals in the US cities, that are most impact by the COVID-19.

Hence, the price of the drug, neither its distribution worldwide, is clear.

Gilead has reportedly said that it is donating 1.5 million individual doses of Remdesivir, which could roughly provide with over 140,000 treatment courses free of cost, in which the emergency distribution in the US is included.
However worldwide, there are over three million confirmed COVID-19 cases, in 185 countries.
The company is aiming for the production of at least 500,000 treatment courses by October, and 1 million treatment courses by December 2020, going on to millions more in 2021 if required.

Saher Asad Mir

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