This week, remdesivir, the antiviral drug developed by Gilead, is showing compelling evidence in trials as a potential treatment for COVID-19 patients. White House public health adviser and the director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said it is “quite a good news” and commented that redemsivir could be the “standard of care.”Embed from Getty Images
NOW, LET’S INTERPRET THE NEWS
WHAT IS REMDESIVIR?
Developed by the biopharmaceutical firm Gilead, remdesivir was previously a failed treatment for Ebola. By design, remdesivir works to disable the mechanism by which certain viruses, including COVID-19, make copies of themselves and potentially overwhelm patients’ immune system.Embed from Getty Images
Currently, remdesivir is an investigational drug for COVID-19 as it is still being studied. According to the FDA, there is limited information known about the safety and effectiveness of this drug. Despite the positive results from trials this week, there are still a lot of things scientists do not know about this drug in regards to COVID-19.
WHAT ARE SOME KEY FINDINGS IN THE NEWLY RELEASED TRIALS?
The results of two trials were released this week in regards to redemsivir and its effectiveness on COVID-19 patients. One trial was conducted by the National Institute of Health (NIH), often referred to as the golden standard of trials to test the safety and efficacy of a new drug. The other trial was a phase three trial conducted by Gilead. Both trials ran out positive.
Major Findings from the NIH Trial – A phase two adaptive, randomized, double-blind, and placebo controlled trials with roughly 1,000 samples.
“Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received a placebo.”The National Institute of Health
1 | Remdesivir resulted in a 31% faster time to recovery 2 | Remdesivir allowed patients to recover four days faster (from a median of 15 days to 11 days) 3| Survival benefit: a mortality rate of 8% for those who received remdesivir compare to 11.6% for those who received a placebo
By significantly reducing recovery time for patients, remdesivir is not only going to be beneficial to COVID-19 patients but also the overwhelmed healthcare system as more hospital beds can be freed sooner for incoming patients.
Shortly after the release of these new findings, the FDA authorized the emergency use of remdesivir for COVID-19. However, this does not mean that remdesivir is now an official FDA approved drug safe and effective for COVID-19 patients. Rather, the authorization to use the drug was only justified for meeting certain criteria, and that there are no other “adequate, approved, and available alternatives” due to the current circumstances.
WHAT DOES IT MEAN FOR THE REST OF THE WORLD?
According to Reuters, Japan immediately announced to fast-track a review of remdesivir after the FDA granted emergency use of the drug for COVID-19 on Friday, May 1. The Japanese Health Minister Katsunobu Kato hope to have the drug approved for domestic use within a week or so.
Despite optimism for the findings, Gilead might not have enough doses of the drug to cover all of the patients in need in Japan so as the rest of the world. In an interview, Gilead Chairman and CEO Daniel O’Day told CNBC that Gilead currently has doses enough for around 100,000 to 200,000 patients worldwide. This may be barely enough to cover patients in the United States, as for today, the State of New York alone has more than 67,000 COVID-19 patients being hospitalized.
However, Gilead is working to have “multiple millions of treatment courses” by the end of the year. Gilead also pledges to completely donate the drug globally and find creative ways to deliver the drug to underdeveloped countries.
“This is a global pandemic. It’s a global problem, and we understand our responsibility here.”Daniel O’Day – Chairman and CEO of Gilead
The Issue of Supply Chain
“You don’t just turn a dial and say, ”Hey, we are going to start making this,” says Bernhardt Trout, a professor of chemical engineering at MIT. Manufacturing remdesivir is a complicated process with multiple layers of work.
First, sorting out active ingredients and additives of the drug could be a gigantic project including testing and making sure it falls within specifications, analyzing impurities, and building a quality control system. Only if everything works and meets all the required standards, manufacturers can scale up the process and speed up the production.
The second challenge is supply chain, since most raw materials and active pharmaceutical ingredients are made in Asia, specifically in India and China. Though China had already flattened the curve and had the outbreak under control, India is still in a state of chaos and nationwide lockdown. Sourcing necessary ingredients in order to produce remdesivir will be a major challenge for Gilead.
Of course, the other possibility for Gilead is to grant licenses to third-party manufactures in countries in order for them to provide enough supply for the lesser-developed parts of the world according to the health and medicine news site STAT.
Jack's take on the issue
Despite positive findings in trials and optimism in the stock market this week, it is essential to emphasize that remdesivir is still being studied and there are still a lot we don’t know about this drug. We don’t know how safe it is for patients, what are some possible side-effects, and to what extent is the drug effective in treating COVID-19 patients. FDA’s emergency authorization does not mean we have found a cure, but it is very possible that remdesivir could be an effective treatment. Regardless, there is still quite a long journey for remdesivir to be fully reviewed.
“Not a lot of people have taken remdesivir. Serious and unexpected side effects may happen. Remdesivir is still being studied so it is possible that all of the risks are not known at this time”The Food and Drug Administration (FDA)
If more compelling evidence comes out suggesting that remdesivir is in fact an effective treatment, supplying and delivering the drug to underdeveloped countries will remain to be major challenges to Gilead. But regardless, remdesivir would be a major step forward in our combat against the novel coronavirus especially when a vaccine is not going to be available for another year or so.
What do you think? Is remdesivir going to be the cure and “standard of healthcare” for COVID-19 patients? What’s the best way Gilead can supply and deliver as much treatment courses as possible to countries around the world? How much positive impact will remdevsivir have on the global pandemic? Leave a comment below!
Published on May 2, 2020 at 11:49 PM EST