GLIMMER OF HOPE' : Gilead Drug Raises "highly significant' Breakthough In Pandemic Fight.
(Reuters) - A top U.S. health official said Gilead Sciences Inc's experimental antiviral drug remdesivir is likely to become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped certain patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a U.S. government trial show that patients given remdesivir had a 31% faster recovery time than those who received a placebo, results hailed by Dr. Anthony Fauci, the nation's top infectious disease expert, as "highly significant."
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness, sending its shares up more than 7%.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important," Fauci told reporters at the White House, likening it to a moment in 1986 "when we were struggling for drugs for HIV and we had nothing."
"This will be the standard of care," Fauci predicted, adding, "The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
The closely watched drug has moved markets in the past few weeks following the release of several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the full data still needs to be analyzed.
President Donald Trump during a White House meeting greeted Gilead's reports as good news.
Interest in Gilead's drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases, until a preventive vaccine emerges.
"There's now enough data to support consideration of access under an emergency use authorization by FDA," former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter.
Gilead provided information on two clinical trials. The study conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.
