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Thursday, October 22, 2020

Explained: Production and current clinical trials of Remdesivir, the drug used in coronavirus treatment

What is Remdesivir? Where is the drug being produced and the various clinical trials it is under currently? We explain.

Written by Tabassum Barnagarwala , Edited by Explained Desk | Mumbai | Updated: October 5, 2020 10:35:27 am
Boxes of Remdisivir anti-viral drug sit on display at the Eva Pharma facility used for its manufacture in Cairo, Egypt, on Aug, 30, 2020. (Sima Diab/Bloomberg)

US President Donald Trump, who was flown to a military hospital near Washington for treatment of Covid-19 on Friday, is undergoing Remdesivir therapy and so far does not require oxygen support, according to a statement from White House Press Secretary Kayleigh McEnany.

What is Remdesivir? Where is the drug being produced and the various clinical trials it is under currently? We explain.

What is Remdesivir?

It is an anti-viral drug that prevents further replication of virus and works best in mildly ill patients and in early stages of hospitalisation. Trump reportedly has “mild symptoms”. Based on advice from specialists of Johns Hopkins and Walter Reed Hospital, he has been administered the first dose of Remdesivir.

The mechanism of novel coronavirus to duplicate is based on RNA-dependent RNA polymerase (RdRp) enzyme. This enzyme helps the RNA in the virus to replicate in a human cell and eventually spread itself. When Remdesivir is injected intravenously, it inhibits this enzyme — in simple terms it makes the enzyme incapable of replicating the coronavirus.

On May 1, the US FDA gave emergency approval to use this drug for critical Covid-19 patients. The drug was manufactured in 2014 for treatment of Ebola by US-based biotechnology Gilead Sciences. It has since been used to treat two members of the coronavirus family, Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome.

Also read | What is the treatment plan for President Donald Trump’s Covid-19?

Production and scale up of Remdesivir 

Gilead is supplying Remdesivir to 127 countries. Daniel O’Day, Chairman of the Board and Chief Executive Officer of Gilead Sciences, in a webinar by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on September 3, said the company will manufacture two million doses by the end of 2020.

O’Day said until January this year, it took 12 months to produce Remdesivir which was eventually compressed to six months. “It is a complex drug. There are 36 chemical processes, some of them can’t work parallel,” he said. He added there is a 44-fold rise in the production of the anti-viral.

Gilead has given licenses to generic manufacturers to increase the drug’s production. O’Day said they decided to price the drug low to provide easy access. The firm is aggressively expanding its supply chain with partners in Europe, North America, and Asia.

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donald trump, donald trump coronavirus, donald trump hospitalised, donald trump covid-19, trump covid-19, US elections, donald trump news President Donald Trump arrives at Walter Reed National Military Medical Center, in Bethesda, on Friday. (AP Photo)

Remdesivir supply in the USA

Earlier this week, Gilead took a decision to sell Remdesivir, branded as Veklury, directly to US hospitals. Before this, for five months, the US Department of Health and Human services had taken the responsibility of allocating the drug to hospitals.

Current clinical trials

According to Gilead’s website, it is working on a number of trials to assess Remdesivir’s efficacy. It is in a Phase 2/3 clinical trial to assess the use of Remdesivir in treatment of peadiatric children. Its ‘simple trial’ is assessing the efficacy of Remdesivir in five-day and 10-day dose in adults. Over 6,000 adults have been enrolled. Initial results showed the anti-viral has success in inhibiting the virus, but data from the expansion phase of the study is expected soon.

Also in Explained | What is the 25th amendment that can be invoked if President Donald Trump falls seriously ill?

Gilead has tied up with Roche for Remdacta trial in which a combination of Remdesivir and Tocilizumab is being used on 450 Covid patients.

The World Health Organization, National Institute of Allergy and Infectious Diseases, Inserm in France, Health authority in China have also undertaken trials that are currently in various phases.

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