October 3, 2020 1:43:25 pm
United States President Donald Trump, who was flown to a military hospital near Washington for Covid-19 treatment 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 produced and the various clinical trials it is currently in? We explain.
What is Remdesivir?
It is an antiviral drug that prevents further replication of the virus and works best in patients with mild illnesses and in the early stages of hospitalization. Trump reportedly has “mild symptoms.” Based on the advice of specialists from Johns Hopkins and Walter Reed Hospital, he has been administered the first dose of Remdesivir.
The replication mechanism of the new coronavirus is based on the RNA-dependent RNA polymerase enzyme (RdRp). This enzyme helps the virus’s RNA to replicate in a human cell and eventually spread. When Remdesivir is injected intravenously, it inhibits this enzyme; in simple terms, makes the enzyme unable to replicate the coronavirus.
On May 1, the US FDA approved emergency use of this drug in critically ill patients with Covid-19. The drug was manufactured in 2014 for the treatment of Ebola by the American biotech Gilead Sciences. Since then, it has been used to treat two members of the coronavirus family, the Middle East respiratory syndrome and the severe acute respiratory syndrome.
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Production and expansion of Remdesivir
Gilead supplies Remdesivir to 127 countries. Daniel O’Day, chairman of the board and chief executive officer of Gilead Sciences, at an International Federation of Pharmaceutical Products Manufacturers and Associations (IFPMA) webinar on September 3, said the company will manufacture two million doses for the purpose of 2020.
O’Day said that until January of 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 cannot work in parallel, ”he said. He added that there is a 44-fold increase in the production of the antiviral.
Gilead has licensed generic manufacturers to increase production of the drug. O’Day said they decided to put a low price on the drug to facilitate access. The firm is aggressively expanding its supply chain with partners in Europe, North America and Asia.
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Remdesivir supply in the US
Earlier this week, Gilead made the decision to sell Remdesivir, under the Veklury brand, directly to US hospitals. Prior to this, for five months, the US Department of Health and Human Services had taken over. the responsibility of assigning the drug to hospitals.
Current clinical trials
According to the Gilead website, it is working on a series of trials to evaluate the effectiveness of Remdesivir. It is in a phase 2/3 clinical trial to evaluate the use of Remdesivir in the treatment of pediatric children. Their “simple trial” is evaluating the efficacy of Remdesivir at 5 and 10 day doses in adults. More than 6,000 adults have registered. Initial results showed that the anti-viral is successful in inhibiting the virus, but data from the expansion phase of the study are expected soon.
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Gilead has partnered with Roche for the Remdacta trial using a combination of Remdesivir and Tocilizumab in 450 Covid patients.
The World Health Organization, the National Institute of Allergy and Infectious Diseases, Inserm in France, the health authority in China have also conducted trials that are currently in various phases.
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