Remdesivir approved by US authorities for emergency use in treatment of coronavirus

Clinical trial data shows drug reduces duration of hospital stays in Covid-19 patients by 31 per cent

Saturday 02 May 2020 16:08 BST

Remdesivir was originally developed to treat Ebola. It blocks some viruses, including the new coronavirus, from duplicating themselves (Pool/AFP/Getty)

An experimental anti-viral drug has been granted emergency authorisation in the US by the Food and Drug Administration (FDA) to be used in treating patients with the coronavirus.

The decision came after a recent clinical trial showed that remdesivir improved the outcomes for those with severe Covid-19.

The National Institutes of Health (NIH) in the US released data indicating that the drug reduced the duration of hospitalisation stays by 31 per cent compared with a placebo treatment. However, the drug was not found to significantly improve chances of survival.

Remdesivir was created by biopharmaceutical company Gilead Science, which said it will donate 1.5 million vials of the drug to help patients in hospitals in the US cities hardest hit by the coronavirus. The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.

The company said that because of a limited supply, priority will be given to hospitals with intensive care units and other hospitals that the government deems to be most in need.

The FDA’s commissioner, Stephen Hahn, said during a meeting at the White House with the US president, Donald Trump: “It’s the first authorised therapy for Covid-19, so we’re really proud to be a part of it.”

Remdesivir was originally developed to treat Ebola. It blocks some viruses, including the new coronavirus, from duplicating themselves and overwhelming the host’s immune system.

Denise Hinton, the FDA’s chief scientist, said in the authorisation letter that there is “no adequate, approved and available alternative to the emergency use of remdesivir for the treatment of Covid-19”.

However, emergency authorisations are not equivalent to full FDA approval, and experts have warned that the drug should not be considered a “magic bullet” in treating Covid-19.

Dr Penny Ward, visiting professor in pharmaceutical medicine at Kings College London, said: “Emergency approval is a mechanism by which the FDA approves medicines, devices or diagnostics which may have shown some usefulness in assisting the management of a national emergency.

“It does not mean that the product is approved for general use but restricts use to a defined circumstance. In this instance, the EUA [emergency use authorisation] for remdesivir restricts use of the product for patients with proven Sars-CoV-2 and very low oxygen saturation.”

Virologist Dr Stephen Griffin, from the University of Leeds, told the research journal Nature: “There is a lot of focus on remdesivir because it’s potentially the best shot we have.

“It may not be the wonder drug that everyone’s looking for, but if you can stop some patients from becoming critically ill, that’s good enough.”

Dr Ward added: “There remains uncertainty about the best time of use and patients likely to benefit most from this treatment, but given that severely ill patients are the most likely to die and that there are no other treatments available, the FDA’s decision to permit use for these patients is reasonable.”

Dr Gillies O’Bryan-Tear, chair of policy and communications at the Faculty of Pharmaceutical Medicine, said: “The FDA has taken a pragmatic decision that, on the balance of evidence, remdesivir is active against this lethal virus, and in the absence of other effective antiviral treatments, and given the widespread healthcare and economic turmoil around the world caused by Covid-19, the right thing to do was to approve its immediate use.

“It’s hard to disagree with this decision, and the hope is that the European Medicines Agency, UK MHRA [Medicines and Healthcare products Regulatory Agency] and other regulatory authorities worldwide will quickly follow suit. Otherwise, non-US patients may be at a disadvantage.”

Speaking in the Oval Office on Friday, Mr Trump praised the drug and said it was a “very promising situation”.

Inside US hospital: A day fighting the coronavirus

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1/13Inside US hospital: A day fighting the coronavirus

Inside US hospital: A day fighting the coronavirus

Cheryll Mack, 46, a registered nurse in the emergency department, poses for a photograph after a 12-hour shift outside the hospital where she works. "The Covid-19 spread has affected a lot of livelihood, a lot of people's lives. It has created a crisis, death in general. So I would like to ask not one single person, but all people worldwide, to converge and join the platform that this is something that nobody can fight individually," said Mack.

Reuters

Inside US hospital: A day fighting the coronavirus

Dr Laura Bontempo, 50, an emergency medicine doctor wears her personal protective equipment she uses when she sees patients, while posing for a photograph after a nine-hour shift, outside the hospital. "The hardest moments have actually been separating families from patients, there is a no-visitor policy now and taking people away from their loved ones is very challenging," Bontempo said. "I'm used to treating sick patients. I treat sick patients all the time. It's very different knowing that the patient you are treating, is actually a risk to you as well. That's the main difference here. No one who works in hospitals is afraid of treating sick people. Just want to keep staff safe and the patients safe at the same time."

Reuters

Inside US hospital: A day fighting the coronavirus

Ernest Capadngan, 29, a registered nurse who works at a biocontainment unit poses for a photograph after a 12-hour shift, outside the hospital. "The hardest moment during the shift was just seeing Covid patients die helpless and without their family members beside them," Capadngan said.

Reuters

Inside US hospital: A day fighting the coronavirus

Martine Bell, 41, a nurse practitioner in an emergency department, poses for a photograph after a six-hour shift outside the hospital where she works. "The hardest thing in all of this, has been taking care of fellow healthcare providers. It really hits home and it's really scary when you see someone that could be you coming in and now you're taking care of them. It's also hitting home that once healthcare providers start getting sick, who is going to be taking care of the public," Bell said. "It's very stressful, everyone is on edge. We don't know who's coming in next, or how sick they're going to be, or if we are going to get a whole bunch of people or if we're not going to get no one. It's a really stressful and just a completely unusual time for all of us."

Reuters

Inside US hospital: A day fighting the coronavirus

Kaitlyn Martiniano, 25, a registered nurse who works at a biocontainment poses for a photograph after a 12.5-hour shift, outside the hospital. "We have a lot of patients and they are pretty sick right now but we have not yet been hit as hard as New York or Seattle, so I feel like we are very lucky with that so far. Every day you have to just be optimistic." Said Martiniano. "I think the reason that we are not being hit as hard right now is because so many things are closed, and because so many people are staying at home."

Reuters

Inside US hospital: A day fighting the coronavirus

Tracey Wilson, 53, a nurse practitioner in an intensive care unit (ICU), poses for a photograph after a 12-hour shift, outside the hospital where she works. "I had a patient fall out of bed today and I had to call his wife and tell her and she couldn't come see him, even though she pleaded and begged to come see him," Wilson said. "There is a lot of unknowns and with that unknown is a lot of anxiety and stress that we're not used to dealing with."

Reuters

Inside US hospital: A day fighting the coronavirus

Meghan Sheehan, 27, a nurse practitioner in an emergency department, poses for a photograph after a 12-hour shift, outside the hospital where she works. "I think the hardest moment has been the fear that lives within all of us. There is a lot of unknown right now. We fear what's going to happen tomorrow, how the emergency department will look next week when we come in. We have fears about our own colleagues, whether they will fall ill. We also fear that we could be asymptomatic carriers and bring this virus home to our families and our loved ones. There has been a lot of fear over our supplies and whether we'll run out. And then obviously there is the fear that we will see patients and not be able to do everything we normally can to help save patients' lives," Sheehan said.

Reuters

Inside US hospital: A day fighting the coronavirus

Kimberly Bowers, 44, a nurse practitioner in an ICU, poses for a photograph after a 13-hour shift, outside the hospital. "The hardest moment was a young woman who died and her family wasn't able to be here with her," Bowers said. "I think right now, it's just frustrating and scary just not knowing what comes next."

Reuters

Inside US hospital: A day fighting the coronavirus

Tiffany Fare, 25, a registered nurse who works at a biocontainment unit poses for a photograph after a 13-hour shift, outside the hospital where she works. "One of the hardest moments was having to see a family member of a Covid patient, say goodbye over an iPad, rooms away. That was a tough one, I can't imagine how hard it would be to be saying goodbye, you can't see your loved one and then they're gone," Fare said. "My team has been really great to me. We've worked really well together and we've really come together in this crisis. We don't really know each other, we all come from different units within the same hospital, so for us to come together and work so well as a team, it's been a journey but I think that's what is giving me hope."

Reuters

Inside US hospital: A day fighting the coronavirus

Dr Kyle Fischer, 35, an emergency medicine doctor, poses for a photograph after a 12-hour shift, outside the hospital where he works. "Since it's a new virus, we don't have any experience with it. For most diseases I am used to seeing it and taking care of it and this, I don't have any starting place. I know what I'm hearing from New York, I've read all of the papers it seems like, but no one knows what the correct answers are, so there's a huge amount of uncertainty and people are really, really sick. So it's hard to second guess whether or not you are doing the right thing when you think you are but you never quite know," said Fischer.

Reuters

Inside US hospital: A day fighting the coronavirus

Julia Trainor, 23, a registered nurse at a surgical ICU, poses for a photograph after a 14-hour shift, outside the hospital. "The hardest moment was having to put a breathing tube in my patient who could no longer breathe for herself and after the breathing tube went in, we called her family and the husband, of course, couldn't visit her because of visitor restrictions at the hospital. So I had to put him on the phone and hold the phone to her ear, as he told her that he loved her so much and then I had to wipe away her tears as she was crying," said Trainor. "I'm used to seeing very sick patients and I'm used to patients dying but nothing quite like this. In the flip of a switch, without the support, they're completely isolated. They're very sick. Some of them recover and some of them don't. But the hardest part, I would think, is them having to go through this feeling like they are alone."

Reuters

Inside US hospital: A day fighting the coronavirus

Lisa Mehring, 45, a registered nurse who works in a biocontainment unit with Covid-19 patients, poses for a photograph after a 12.5-hour shift, outside the hospital where she works in Maryland. "Seeing these new moms have babies has been the hardest moment along with having do their pumping for the new moms and them not being able to be with their newborn children, it's hard to think of the family that they are missing," Mehring said.

Photos Reuters

Inside US hospital: A day fighting the coronavirus

Jacqueline Hamil, 30, a registered nurse in an emergency department, poses for a photograph after a 12-hour shift outside the hospital. "The hardest moment of my shift today, I was in charge, and we had a really sick patient that was in a really, really small room and usually, when we have sick crashing patients, we can have a ton of resources and a ton of staff go in and help with the nurse and the doctors that are taking care of that patient. But due to the patient being ruled out for the coronavirus, we could only have five or six people in the room at a time and putting on all the gowns and gloves and masks and face shields to protect us in case the patient does have coronavirus, it takes a while, so the nurse that was in there, ended up being in the room for you know 6, 7 hours with minimal breaks and it was hard being in charge and knowing that she was stuck in the room and really nothing I could do to help her," Hamil said.

Reuters

Daniel O’Day, chief executive of Gilead Sciences, said: “We will be working very closely to get [remdesivir] to patients, working with FEMA, working with other parts of the government to make sure that we get that to the patients in need as quickly as possible because there are patients out there that can benefit from this medicine today that are hospitalised.

“We don’t want any time to waste for that.”

The US has the most cases and fatalities in the world at more than 1 million and at least 63,200 respectively, with much of the country in lockdown in an effort to contain the spread of the virus.

Additional reporting by agencies

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