Washington: The Food and Drug Administration has granted emergency use authorization for Gilead Sciences’ remdesivir drug 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 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. Gilead is donating 1.5 million vials of remdesivir.
Gilead shares pared losses on the news, and closed Friday down 4.8% at $79.95. However, the stock was up nearly 2% in extended trading. It has a market value of about $101 billion and 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 a fact sheet from the agency 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, new clinical trial data suggests. Without other proven treatments, health-care workers will likely be considering its use.
The FDA previously authorized the emergency 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.
″[The National Institutes of Health], FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19,” Health and Human Services Secretary Alex Azar said in a statement Friday.
