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The Food and Drug Administration has granted emergency use authorization for the drug remdesivir from Gilead Sciences to treat Covid-19, the disease caused by 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 who brought back to this point and many of our people who have been part of this, in fact, the caregivers,” O’Day told reporters. Gilead is donating 1.5 million vials of remdesivir.
Gilead shares cut losses on the news and closed Friday with a 4.8% drop to $ 79.95. However, the stock rose nearly 2% in extended trading. It has a market value of approximately $ 101 billion and has gained 21% since the beginning of the year.
The EUA means that remdesivir has not undergone the same level of review as an FDA-approved treatment, according to an agency fact sheet on the drug. However, doctors will be able to use the medication in hospitalized patients with the disease, even if the medication has not been formally approved by the agency.
The intravenous medication has helped shorten the recovery time of some hospitalized patients with Covid-19, new clinical trial data suggests. Without other proven treatments, healthcare workers will likely consider using it.
The FDA previously authorized the emergency use of antimalarial drugs, chloroquine and hydroxychloroquine to treat Covid-19. However, he later issued a warning against taking medications outside a hospital or in a formal clinical trial setting after learning of reports of “serious heart rhythm problems” in patients.
Earlier in the week, White House health adviser Dr. Anthony Fauci said data from a coronavirus drug test trial that tested the Gilead drug showed “very good news” and set a new standard. of care for Covid-19 patients. The National Institute of Allergy and Infectious Diseases published the results of their study showing that Covid-19 patients who took remdesivir generally recovered after 11 days, four days faster than those who did not take the drug.
Gilead also published preliminary results from its own study, showing that at least 50% of patients treated with a five-day remdesivir dose improved. 397 patients with severe cases of Covid-19 participated in the clinical trial. The severe study is a “single arm” study, meaning that it did not evaluate the drug against a control group of patients who did not receive the drug.
“[The National Institutes of Health]”The FDA and scientists across the United States and around the world have worked tirelessly with patients to obtain this new potential treatment for COVID-19,” Secretary of Health and Human Services Alex Azar said Friday.
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 fast as possible” to approve the drug.
“We would like to see very fast approvals, especially with things that work,” he said at a White House roundtable with business executives Wednesday night.
The drug has not been formally approved to treat the virus, and US health officials. USA They caution that the new data on the drug has not yet been peer-reviewed. Even though the drug was awarded for emergency use, there are still several clinical trials underway that test the drug to see if it is effective in stopping the replication of the coronavirus.
Remdesivir has shown promise in treating SARS and MERS, which are also caused by coronaviruses. Some health authorities in the US The United States, China, and other parts of the world have been using remdesivir, which has been tested as a possible treatment for the Ebola outbreak, in hopes that the drug may improve outcomes for Covid-19 patients.
Researchers have noted that the drug’s side effects may include nausea and vomiting, as well as possible liver damage.
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 do 1 million rounds by the end of this year. Gilead said he will be able to produce “several million” of his antiviral medicine next year.
According to the EUA, the FDA will allow the drug to be administered for either a five-day or a 10-day dose. A 10-day treatment regimen is preferred for intubated patients.
“That will allow Gilead to effectively double supply,” said former FDA Commissioner Scott Gottlieb during an interview on CNBC’s “Closing Bell”.
The company said it will continue to support clinical trials and expand so-called compassionate use programs to remdesivir.
Read Gilead’s full press release here.
Correction: Gilead is donating 1.5 million vials of remdesivir. An earlier version of this story misread quantity.
