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(CNN) – The federal government will begin sending “tens of thousands” of remdesivir courses earlier this week and will decide where the drug goes, according to Daniel O’Day, president and CEO of Gilead Sciences, the maker of the investigational drug.
In the first results of a trial sponsored by the National Institutes of Health, remdesivir was found to shorten the duration of illness in patients with severe Covid-19, but had no statistically significant effect on whether the patients died.
“We intend to obtain [remdesivir] to patients in the first part of next week, starting to work with the government, which will determine which cities are most vulnerable and where are the patients who need this drug, “O’Day said on CBS’s” Face the Nation “. Weekend.
CNN has contacted the US Department of Health and Human Services. USA For feedback on how medications will be distributed.
The government will begin to send ‘tens of thousands of treatment courses’
Earlier this week, the US Food and Drug Administration. USA He authorized remdesivir for emergency use in patients with severe Covid-19, and Gilead previously announced that he would donate his existing supply of the drug.
“What we will do is provide that donation to the US government, and they will determine, based on things like ICU beds, where the course of the epidemic lies in the United States. They will start sending tens of thousands of early treatment courses “this week and we will adjust it as the epidemic changes and evolves in different parts, in different cities here in the United States,” O’Day said Sunday.
His comments echo the FDA’s emergency use authorization for the drug, which states: “The distribution of the authorized remdesivir will be controlled by the United States Government for use consistent with the terms and conditions of this USA “.
Gilead has donated 1.5 million vials of the drug, O’Day said, which is equivalent to between 100,000 and 200,000 courses of treatment, depending on how long patients take it.
“This donation will be available to patients here in the United States and around the world as other regulatory decisions are made for those countries,” he said.
When asked if the Trump administration has discussed using the Defense Production Law to order prioritization of the US market. USA On foreign markets, O’Day said: “I think we are aligned with the US government so we can also make sure, as a global company based here in the United States, that we can also serve other countries in the world “
CBS’s Margaret Brennan then asked for confirmation: “So they haven’t talked to you about ordering the US market to be prioritized, or taking it for the arsenal, for example. Can you still export it?”
“That’s correct,” said O’Day. “We have been exporting thousands of courses of treatment for clinical trials and for compassionate use. And our collaboration with the government has been such that we have been very transparent with them here in the United States, and have a good relationship in the future assignment. “
The company expects to produce one million treatment courses by the end of the year.
When asked for clarification on whether all 1.5 million vials would be donated to the US government. “As suggested by O’Day, Gilead spokeswoman Sonia Choi said:” We intend to allocate our available supply based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment. “
She said the company “is working with regulatory authorities around the world and bioethicists to help inform our global allocation approach.”
In a press release on Friday, Gilead said his goal is to produce at least 500,000 treatment courses by October and more than a million by December.
The FDA-authorized drug is infused intravenously and its use is limited to hospitalized patients with severe illness. But O’Day said Gilead is also looking at other formulations of remdesivir, including an inhaled version that could be administered outside of the hospital.
This story was first published on CNN.com ‘The US Government. USA Decide where remdesivir goes in the midst of a coronavirus pandemic, says drug maker ‘
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