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Gilead Drug Is Cleared for Emergency Use by FDA, Trump Says
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May 1, 2020, 3:46 PM EDT
https://www.bloomberg.com/news/articles/2020-05-01/gilead-drug-is-cleared-for-emergency-use-by-fda-trump-says
Gilead said earlier this week it has about 50,000 courses of the drug ready to distribute. The company has been in talks with the FDA about how the drug will be used, and said it expects the antiviral medication to be a backbone of therapy as well as proof that other drugs can target the virus. It's also examining how to increase manufacturing of the drug.
It's also started to face questions about how, or if, it will make money on the product. After reporting quarterly earnings on Thursday, financial analysts on a call with the company asked what its long-term plans were for the drug after it dispenses an early round of the treatment for free.
"There has been no other time like this in the history of the planet," Chief Executive Officer Daniel O'Day said on the call. "There is no rule book out there, other than that we need to be thoughtful about how we can make sure we provide access of our medicines to patients around the globe and do that in a sustainable way for the company, for shareholders, and we acknowledge that."
FDA Allows For 'Emergency Use' of Remdesivir, Experimental Coronavirus Drug
May 1, 2020 4:14 PM EDT
https://time.com/5831062/fda-allows-emergency-use-remdesivir/
Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more.
No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.
(WASHINGTON) - U.S. regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide.
The Food and Drug Administration acted after preliminary results from a government-sponsored study showed that Gilead Sciences' remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.
Gilead gets emergency FDA authorization for remdesivir to treat coronavirus, Trump says
Published Fri, May 1 2020 3:46 PM
https://www.cnbc.com/2020/05/01/gilead-gets-emergency-fda-authorization-for-remdesivir-to-treat-coronavirus-trump-says.html
Key Points
• The Food and Drug Administration has granted emergency use authorization for Gilead's remdesivir drug to treat the coronavirus, President Donald Trump announced Friday.
• Trump made the announcement in the oval office alongside Gilead CEO Daniel O'Day.
• The EUA means that remdesivir has not undergone the same level of review as an FDA-approved treatment, according to an FDA fact sheet on the drug.
The Food and Drug Administration has granted emergency use authorization for Gilead Sciences remdesivir drug to treat the coronavirus, President Donald Trump announced Friday.
Trump made the announcement in the Oval Office alongside Gilead CEO Daniel O'Day.
"We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers," O'Day told reporters. He added that the company is donating one million vials of remdesivir.
Gilead shares pared losses, but were still down 4% in trading Friday. The stock, which has a market value of about $101 billion, has gained 21% since the start of the year.
The EUA means that remdesivir has not undergone the same level of review as an FDA-approved treatment, according to an FDA fact sheet on the drug. However, doctors will be allowed to use the drug on patients hospitalized with the disease even though the drug has not been formally approved by the agency.
The intravenous drug has helped shorten the recovery time of some hospitalized Covid-19 patients. Without other proven treatments, health-care workers will likely be considering its use.
The FDA previously authorized the use of malaria drugs chloroquine and hydroxychloroquine to treat Covid-19. However, it later issued a warning against taking the drugs outside a hospital or formal clinical trial setting after it became aware of reports of "serious heart rhythm problems" in patients.
Earlier in the week, White House health advisor Dr. Anthony Fauci said data from a coronavirus drug trial testing Gilead's drug showed "quite good news" and sets a new standard of care for Covid-19 patients.
The National Institute of Allergy and Infectious Diseases released results from its study showing Covid-19 patients who took remdesivir usually recovered after 11 days, four days faster than those who didn't take the drug.
Gilead also released preliminary results from its own study, showing at least 50% of the patients treated with a five-day dosage of remdesivir improved. The clinical trial involved 397 patients with severe cases of Covid-19. The severe study is "single-arm," meaning it did not evaluate the drug against a control group of patients who didn't receive the drug.
Trump has touted remdesivir as a potential treatment for the virus, which has infected more than 3.3 million people worldwide and killed at least 237,000 people, according to data compiled by Johns Hopkins University. Earlier this week, he said he wanted the FDA to move "as quickly as they can" to approve the drug.
"We would like to see very quick approvals, especially with things that work," he said at a roundtable at the White House with business executives Wednesday evening.
The drug has not been formally approved to treat the virus, and U.S. health officials caution new data on the drug has yet to be peer-reviewed.
On Thursday, the company said it expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May and anticipates it can make 1 million rounds by the end of this year. Gilead said it will be able to produce "several million" rounds of its antiviral drug next year.
Gilead spent $50 million on the research and development of remdesivir during the first quarter, it disclosed in its earnings report Thursday. The company said it will spend as much as $1 billion for the year.
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