The FDA has authorized emergency use of the Ebola drug remdesivir for treating the coronavirus.
The authorization means the anti-viral drug can now be used on people who are hospitalized with severe Covid-19.
A recent clinical trial showed remdesivir helped shorten the recovery time for people who were seriously ill.
However, the drug did not significantly improve survival rates.
Experts have warned remdesivir – which was originally developed to treat Ebola, and is produced by Gilead pharmaceutical company in California – should not be seen as a “magic bullet” for coronavirus.
Remdesivir interferes with the virus’s genome, disrupting its ability to replicate.
During a meeting with President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O’Day said the FDA authorization was an important first step.
Gilead would donate 1.5 million vials of the drug, he said.
FDA Commissioner Stephen Hahn also said at the meeting: “It’s the first authorized therapy for Covid-19, so we’re really proud to be part of it.”
Emergency FDA authorization is not the same as formal approval, which requires a higher level of review.
Remdesivir did not cure Ebola, and the producing company says on its website: “Remdesivir is an experimental medicine that does not have established safety or efficacy for the treatment of any condition.”
Gilead also warns of possible serious side-effects.
However, President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus.
In its clinical trial, whose full results are yet to be released, the US National Institute of Allergy and Infectious Diseases (NIAID) found that remdesivir cut the duration of symptoms from 15 days down to 11.
The trials involved 1,063 people at hospitals around the world – including the US, France, Italy, the UK, China and South Korea. Some patients were given the drug and others were given a placebo (dummy) treatment.
Dr. Anthony Fauci, who runs NIAID, said that remdesivir had “a clear-cut, significant, positive effect in diminishing the time to recovery”.
However, although remdesivir may aid recovery – and possibly stop people having to be treated in intensive care – the trials did not give any clear indication whether it can prevent deaths from coronavirus.
As much remains uncertain about the treatment regime, Gilead suggests a 10-day dosing duration for patients on ventilators and five days for patients who are not.
The FDA’s jurisdiction does not stretch overseas so the authorization only applies to US. Experts also stressed that the emergency use is not the same as full approval.
The experimental Ebola drug ZMapp shows it is 100% effective in monkey studies, even in later stages of the infection, the only clinical trial data showed.
The study’s findings have been published in Nature.
Yet the limited supplies will not help the 20,000 people predicted to be infected during the outbreak in West Africa.
Two out of seven people given the drug, have later died from the disease.
ZMapp has been dubbed the “secret serum” as it is still in the experimental stages of drug development with, until now, no public data on effectiveness.
Doctors have turned to it as there is no cure for Ebola, which has killed more than 1,500 people since it started in Guinea.
Researchers have been investigating different combinations of antibodies, a part of the immune system which binds to viruses, as a therapy.
ZMapp shows it is 100 percent effective in monkey studies, even in later stages of the Ebola infection
Previous combinations have shown some effectiveness in animal studies. ZMapp is the latest cocktail and contains three antibodies.
Trials on 18 rhesus macaques infected with Ebola showed 100% survival.
This included animals given the drug up to five days after infection. For the monkeys this would be a relatively late stage in the infection, around three days before it becomes fatal.
Scientists say this is significant as previous therapies needed to be given before symptoms even appeared.
One of the researchers, Dr. Gary Kobinger from the Public Health Agency of Canada, said this was a huge step up from previous antibody combinations.
“The level of improvement was beyond my own expectation, I was quite surprised that the best combination would rescue animals as far as day five, it was fantastic news.
“What was very exceptional is that we could rescue some of the animals that had advanced disease.”
However, there is always caution when interpreting the implications for humans from animal data.
A Liberian doctor, one of three taking the drug in the country, and a Spanish priest both died from the infection despite ZMapp treatment.
The course of the infection is slower in humans than macaques so it has been cautiously estimated that ZMapp may be effective as late as day nine or 11 after infection.
But Dr. Gary Kobinger said: “We know there is a point of no return where there is too much damage to major organs, so there’s a limit.”
The group wants to start clinical trials in people to truly assess the effectiveness of the drug.
ZMapp, the experimental drug given to Dr. Kent Brantly and Nancy Writebol to fight the Ebola virus, seems to be working, according to health specialists.
The untested drug was developed by San Diego-based Mapp Biopharmaceuticals.
What we need to know about ZMapp:
1. ZMapp is made from tobacco leaves
ZMapp is made from the leaves of modified tobacco plants, specifically, the Nicotiana benthamiana plant, Bloomberg reported. The tobacco leaves, which typically do more harm than good in regard to human health, help combat the Ebola virus because of the compound that’s created from their modification. The combination of compounds in ZMapp includes a compound called MB-003 and another called ZMAb. MB-003 protected 100% of monkeys exposed to the Ebola virus immediately after exposure. ZMAb provided 100% survival to monkeys one day after exposure. That number decreased to 50% after two days, according to NBC News. Erica Ollmann Saphire, a professor of immunology at the Scripps Research Institute in La Jolla, California, said that one of the antibodies in the serum helps alert the immune system to the presence of infected cells so they can be destroyed. The other two antibodies seem, “to neutralize the virus,” Prof. Erica Ollman Saphire told WebMD.
ZMapp, the experimental drug given to Dr. Kent Brantly and Nancy Writebol to fight the Ebola virus, seems to be working
2. ZMapp had never before been tested in humans
The drug had never been tried before in humans with Ebola, but had shown promise in monkeys with the disease. Both Dr. Kent Brantly and Nancy Writebol knew the drug had never been tested in humans before taking it. Their improving conditions have left researchers optimistic about the effectiveness of ZMapp. Thomas Geisbert, a professor of infectious disease at The University of Texas Galveston Medical Branch, told WebMD: “If we can prove that whatever the treatment was worked, that’s fantastic. That’s exciting. But I’m cautiously optimistic, because with this particular outbreak, almost 40 percent of patients survive without treatment. So we want to make sure that it wasn’t somebody that was going to survive anyway.”
3. ZMapp’s creation was a collaborative effort
ZMapp was the result of collaboration among Mapp Pharmaceuticals, San Diego-based LeafBio, Defyrus in Canada and the Public Health Agency of Canada, according to Times of San Diego.
Mapp Pharmaceuticals said in a statement: “ZMapp was first identified as a drug candidate in January 2014 and has not yet been evaluated for safety in humans. As such, very little of the drug is currently available. Mapp and its partners are cooperating with appropriate government agencies to increase production as quickly as possible.”
4. ZMapp’s use has raised ethical questions
The use of ZMapp has raised ethical questions regarding who has the right to experimental treatment, Bloomberg reported. Robert Garry, a virologist at Tulane University, told the publication: “There are a lot of Africans that are also dying. If we are going to do it for the Americans then we should certainly step up our game for the Africans.”
Liberia’s assistant health minister, Tolbert Nyenswah, told The Wall Street Journal health officials have become inundated with requests from the families of Ebola patients for ZMapp.
5. Mapp Biopharmaceuticals was part of a group awarded a $28 million grant to fight Ebola
Mapp Biopharmaceuticals was one of several companies and research to be selected for a five-year grant of up to $28 million awarded by the National Institutes of Health in order to fight Ebola, according to The Scripps Research Institute.
The Ebola infected US aid workers, Dr. Kent Brantly and Nurse Nancy Writebol, appear to be improving after receiving an experimental drug, officials have said.
It is not clear if the ZMapp drug, which has only been tested on monkeys, can be credited with their improvement.
Dr. Kent Brantly was flown from Liberia to Atlanta for treatment on Saturday. His colleague Nancy Writebol arrived back in the city of Atlanta on Tuesday.
Since February, 887 people have died of Ebola in four West African countries.
The World Bank is allocating $200 million in emergency assistance for countries battling to contain the Ebola outbreak.
Dr. Kent Brantly and Nurse Nancy Writebol’s condition appear to be improving after receiving Ebola experimental serum ZMapp
It is the world’s deadliest outbreak to date and has centered on Guinea, Liberia and Sierra Leone. There have also been two cases in the Nigerian city of Lagos, where eight people are currently in quarantine.
British Airways has temporarily suspended flights to and from Liberia and Sierra Leone until August 31, 2014, because of the health crisis, the airline said in a statement. It follows a similar suspension by two regional air carriers last week.
The Ebola virus spreads by contact with infected blood and bodily fluids. The current outbreak is killing between 50% and 60% of people infected.
There is no cure or vaccine for Ebola – but patients have a better chance of survival if they receive early treatment.
Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, says clinical trials are to start in September on an Ebola vaccine that has shown promising results during tests on animals.
Dr. Kent Brantly and Nancy Writebol were treated with the ZMapp serum before their evacuation from Liberia.
According to a CNN report, quoting a doctor in Liberia, Dr. Kent Brantly’s condition improved dramatically within an hour of receiving the drug.
Service in Mission (SIM), the Christian aid group that employs Nancy Writebol, says she has had two doses of the drug and did not respond as well as Dr. Kent Brantly but she is showing “improvement”.
“She is walking with assistance… strength is better… has an appetite,” SIM spokesman Palmer Holt told the Washington Post newspaper in an email on Monday.
Nancy Writebol is on her way to a special isolation ward at Atlanta’s Emory University Hospital, where Dr. Kent Brantly is being treated by infectious disease specialists.
British scientists at University of Cambridge say they may have found a more efficient treatment of pancreatic cancer after promising early trial results of an experimental drug combination.
Giving the chemotherapy agent gemcitabine with an experimental drug called MRK003 sets off a chain of events that ultimately kills cancer cells, studies in mice show.
Patients are now testing the treatment to see if it will work for them.
The Cancer Research UK-funded trials are being carried out in Cambridge.
Father-of-two Richard Griffiths, 41, from Coventry, has been on the trial since being diagnosed with pancreatic cancer in May 2011.
“After six cycles of treatment, a scan showed the tumours had reduced and so I have continued with the treatment,” Richard Griffiths said.
“The trial gives you hope – I really feel I can do this with the science behind me.”
Cancer Research UK says it is prioritizing research into pancreatic cancer because the survival rate still remains dismally low.
Survival rates in pancreatic cancer are very low in relation to other cancers, and the length of time between diagnosis and death is typically short, usually less than six months.
The most recent data for UK show that about 16% of patients survive the disease beyond 12 months after diagnosis – prompting the need for new treatments.
Professor Duncan Jodrell, who is leading the trials at the University of Cambridge, said: “We’re delighted that the results of this important research are now being evaluated in a clinical trial, to test whether this might be a new treatment approach for patients with pancreatic cancer, although it will be some time before we’re able to say how successful this will be in patients.”
In total, about 60 patients with advanced pancreatic cancer will be recruited for the first Phase I/II clinical trial.
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