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 foundation run by former Microsoft boss Bill Gates and his wife Melinda has pledged $5.7 million towards a program to increase production of experimental Ebola treatments in Guinea and other affected countries.
The program will focus on treatments derived from the blood of survivors.
The Bill and Melinda Gates Foundation also said the grant would be used to evaluate new experimental drugs.
More than 5,000 people have died in the current Ebola outbreak – almost all of them in West Africa.
There is currently no licensed treatment or vaccine for the Ebola virus. Hospital treatment is based on giving patients fluids to stop dehydration and antibiotics to fight infections.
There are several experimental vaccines and drug treatments for Ebola under development, but these have not yet been fully tested for safety or effectiveness.
The medical charity Medecins Sans Frontieres (MSF) is to start clinical trials of some of these treatments in West Africa in December.
The foundation said that it would work with several private partners to develop convalescent plasma treatments.
The treatments would use blood donated from Ebola survivors who had been screened for diseases.
The liquid plasma from the blood, containing disease-fighting antibodies, would then be isolated and given directly to patients.
The remaining blood could then be returned to the donor, allowing them to donate blood at a faster rate than before.
Dr. Papa Salif Sow, an infectious diseases expert working with the foundation, said that the program would work with governments to “to rapidly identify and scale up potential lifesaving treatments”.
“The Gates Foundation is focusing its R&D investments on treatments, diagnostics, and vaccines that we believe could be quickly produced and delivered to those who need them if they demonstrate efficacy in stopping the disease,” he said.
Clinical trials for an effective Ebola treatment are to start in West Africa in December.
The medical charity Medicins Sans Frontieres (MSF), which has been helping lead the fight against the virus, says three of its treatment centers will host three separate research projects.
Meanwhile, Liberia’s President Ellen Johnson Sirleaf has lifted the state of emergency imposed in the country.
Ellen Johnson Sirleaf warned “this is not because the fight against Ebola is over”.
It marks the progress being made in the country, where the weekly number of new infections is falling.
In a radio address she told the nation that night curfews would be reduced, weekly markets could take place and preparations were being made for the re-opening of schools.
One trial involves using the blood of recovered Ebola patients to treat sick people in the Guinean capital Conakry.
Clinical trials for an effective Ebola treatment are to start in West Africa in December (photo Getty Images)
Two antiviral drugs will be trialed in Guinea and an unconfirmed location.
“This is an unprecedented international partnership which represents hope for patients to finally get a real treatment,” said MSF spokeswoman Dr. Annick Antierens.
The Ebola outbreak is thought to have infected more than 14,000 people, almost all of them in West Africa. The death toll has risen to 5,160.
The first trials are due to start next month. Initial results could be available in February 2015.
The World Health Organization (WHO) announced in September that experimental treatments and vaccines for Ebola should be fast-tracked.
Two experimental vaccines, produced by GlaxoSmithKline (GSK) and the Public Health Agency of Canada, have already been fast-tracked into safety trials.
The GSK vaccine is being tested in Mali, the UK and the US. Research on the Canadian vaccine is also under way in the US.
Around 400 people participate in the first trials and they will be extended to other centers if the early results are promising.
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.
Liberia will receive ZMapp, an untested experimental Ebola drug, to treat infected patients, the government announces.
The move came after a request to the US from Liberian President Ellen Johnson Sirleaf, the government said.
The news came as medical ethics specialists met in Geneva to explore the use of such new treatments.
The World Health Organization (WHO), which is hosting the meeting, says some 1,013 have died from Ebola in West Africa.
US government officials said their role had been to put Liberian officials in contact with ZMapp maker Mapp Biopharmaceutical.
The pharmaceutical company said its supply of the drug was exhausted after its supplies were sent to West Africa, AFP news agency reported.
Liberia will receive an untested experimental drug, Zmapp, to treat people infected with Ebola
The drug was “provided at no cost in all cases,” the company added.
ZMapp has been used in the US on two aid workers who have shown signs of improvement, and a Roman Catholic priest, infected with Ebola in Liberia, who is currently being treated in a hospital in Madrid.
However, the drug has only been tested on monkeys and has not been yet evaluatd for safety in humans.
The WHO will announce the outcome of its emergency meeting on the role of experimental drugs on Tuesday.
Earlier, Ivory Coast announced it had banned all passenger flights from the three countries hit the worst by the spread of Ebola: Guinea, Liberia and Sierra Leone.
It is the second country, after Saudi Arabia, to impose such a ban in a bid to prevent the spread of the deadly virus.
There is no cure for Ebola, which has infected at least 1,779 people since the outbreak was first reported in Guinea in February.
Ebola’s initial flu-like symptoms can lead to external haemorrhaging from areas like eyes and gums, and internal bleeding which can lead to organ failure. Patients have a better chance of survival if they receive early treatment.
Meanwhile, China has sent medical supplies worth 30 million yuan ($4.9 million) to Liberia, Sierra Leone and Guinea to help fight against the disease.
Separately, the Chinese ambassador to Sierra Leone said on Monday that eight Chinese medical workers who had been treating Ebola patients had been placed in quarantine for the past two weeks in the capital.
Nigeria, Africa’s most populous country, confirmed a 10th case of Ebola on August 11.
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