USA approves Remdesivir for emergency use for coronavirus patients
President Donald Trump announced Friday that the FDA has approved the experimental drug remdesivir for emergency use in hospitalized coronavirus patients.
'I'm pleased to announce that Gilead now comes with an E wave from the FDA for remdesivir,' Trump said.
It is the first drug shown to help fight the disease, which has killed more than 64,000 people in the usa.
Gilead's chief executive officer Daniel O'Day, whose company produces remdesivir joined President Trump, Vice President Pence, Dr. Deborah Birx, Health and Human Services Secretary Alex Azar and FDA Commission Stephen Hahn for the announcement.
O'Day pledged to donate 1.5 million doses of the drug to help patients in need.
'What I'd like to say on behalf of Gilead and the president's point, we feel a tremendous responsibility. We are humbled with this first step for hospitalized patients. We wish to make certain nothing gets in the form of these patients obtaining the medicine. So we determined to donate 1.5 million vials of remdesivir. We will be working with the federal government to determine how better to distribute that within the United States,' he said.
'We will be working very closely to get that to patients, working with FEMA and other areas of the government to make certain that people get that to the patients in need as fast as possible. There are patients out there that can benefit from this medicine today that are hospitalized. We don't want any moment to waste for that,' he added.
The company has been pushing for FDA approval of the drug. It had been given after preliminary results from a government-sponsored study showed that remdesivir shortened enough time to recovery by 31 %, or about four days typically, for hospitalized coronavirus patients.
The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after President Trump promoted it.
The antiviral remdesivir has demonstrated promise for treating coronavirus, and the head of the drug's maker, Gilead Sciences, said he's focused on ensuring anyone who needs the drug could have access to it.
'We're likely to work very closely with the federal government and with healthcare systems to ensure that it's accessible, that it is affordable to governments,' said O'Day in conversation with Stat News.
'We're going to make certain that access isn't a concern with this medicine.'
A list price for remdesivir is not available but a recently available study published in the Journal of Virus Eradication discovered that manufacturing a 10-day treatment course would cost about $9.
Earlier this year, Gilead donated its 1.5 million dose stockpile of remdesivir for research on its use for treating coronavirus like the NIH study that Dr Anthony Fauci said Wednesday suggested that the drug 'can block this virus.'
On Thursday, the Gilead said within an earnings report that it could make 140,000 treatment courses by the finish of May (although O'Day slightly revised this estimation in conversation with Stat) and 'several million' courses during the period of next year.
'This is a worldwide pandemic,' O'Day said to Stat.
'There should be no question about our capability to get medicine in the hands of patients, and that is how we will approach the time period following the donation.'
His company has already begun ramping up production of remdesivir, a drug it at first developed to treat Ebola, though it flopped in trials for that disease.
O'Day said that the company currently has enough remdesivir readily available for a lot more than 50,000 10-day treatment courses.
'Look, I think we understand the duty that people have as a company,' O'Day said.
'That's specifically why, as we thought through the very best approach to making this drug available in the early days, we thought it was very vital that you move with a donation of our entire existing supply.
'First of all, it's the ideal thing to do. And secondly, it had been going to facilitate access in recognition of the public health emergency and the actual fact that data was still developing on the medicine and regulatory processes were still underway.
'We didn't want usage of be encumbered at all in the beginning, which explains why we just went for a donation right up front of 1 1.5 million doses.'
