FDA on Friday expanded its emergency use authorization (EUA) for Gilead Sciences' experimental Covid-19 treatment remdesivir to allow providers to use the drug to treat all hospitalized patients with Covid-19, but evidence on whether the drug is clinically beneficial for all hospitalized Covid-19 patients is mixed.
US new coronavirus cases surpass 6M, deaths near 183K
The move comes as U.S. officials as of Monday morning had reported a total of 6,008,300 cases of the novel coronavirus virus since the country's epidemic began—up from 5,883,700 cases reported as of Friday morning.
The United States' reported total of coronavirus cases rose from five million to six million in a period of 22 days. That suggests the country's coronavirus epidemic has slowed in recent weeks, as the country's total number of coronavirus cases had swelled from four million to five million in a period of 16 days. According to a CNBC analysis of data from Johns Hopkins University, the average number of newly reported novel coronavirus cases in the United States decreased by 5% last week when compared with the previous week, falling to an average of 41,638 newly reported infections per day.
However, some states, particularly in the Midwest, are continuing to see growth in their daily numbers of newly reported coronavirus cases. Data from the New York Times shows that Guam and nine states—Alabama, Connecticut, Iowa, Kansas, Maine, Minnesota, North Carolina, North Dakota, and South Dakota—saw their average daily numbers of newly reported coronavirus cases rise over the past 14 days.
According to Reuters, Iowa, Minnesota, North Dakota, and South Dakota have recently reported record-high single-day increase in their numbers of new coronavirus cases, and Idaho and Montana have reported record-high increases in their numbers of hospitalized patients with Covid-19, the disease caused by the virus.
The Times' data also shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in 26 states: Alaska, Arkansas, Colorado, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, West Virginia, and Wisconsin.
In addition, the Times' data shows that Puerto Rico; Washington, D.C.; the U.S. Virgin Islands; and 15 states saw their average daily numbers of newly confirmed coronavirus cases decrease over the past 14 days: Arizona, California, Delaware, Florida, Georgia, Idaho, Louisiana, Maryland, Nevada, New Mexico, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
U.S. officials as of Monday morning also had reported a total of 182,986 deaths linked to the coronavirus since the country's epidemic began—up from 180,731 deaths reported as of Friday morning.
According to the Times' data, 15 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Arkansas, Hawaii, Idaho, Iowa, Kentucky, Massachusetts, Missouri, Montana, Nebraska, Oklahoma, Oregon, Rhode Island, Tennessee, Virginia, and West Virginia.
FDA expands EUA for remdesivir, allowing use for all hospitalized patients with Covid-19
As the novel coronavirus continues to spread throughout the United States, FDA on Friday expanded its EUA for the experimental Covid-19 treatment remdesivir, allowing providers to use the medication to treat "all hospitalized adult and pediatric patients with suspected or laboratory-confirmed Covid-19, irrespective of their severity of disease."
The change comes after FDA in May had issued an EUA allowing providers to use remdesivir to treat hospitalized patients with severe cases of Covid-19. FDA issued that initial EUA based on preliminary data released by NIH that showed hospitalized patients with severe cases of Covid-19 who were treated with remdesivir had a 31% faster recovery time on average than patients who received a placebo.
FDA on Friday said it expanded that EUA based on new data published earlier this month in JAMA from a randomized clinical trial involving 584 hospitalized patients with moderate cases of Covid-19. The data showed that, among those patients, those who were treated with remdesivir for up to five days were more likely to see improvements in certain aspects of their health, including whether they needed supplemental oxygen, when compared with those who received standard Covid-19 care. According to the study, "patients randomized to a five-day course of remdesivir had a statistically significant difference in clinical status compared with standard care."
However, the study also stated that the difference in the patient groups' clinical status "was of uncertain clinical importance." Further, the study noted, "Among patients with moderate Covid-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment."
Still, FDA said that, based on the new study's data, it is "reasonable to believe" remdesivir may be an effective treatment for all hospitalized adult and pediatric patients with Covid-19, and that the experimental treatment's benefits outweigh its risks.
FDA Commissioner Stephen Hahn said, "The data show[s] that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus."
Is there enough evidence to support the expanded EUA?
But USA Today reports that "[n]o other studies have been published supporting more widespread use of remdesivir," and some experts have questioned whether there's sufficient evidence to support the expanded EUA.
Eric Topol, VP for research at Scripps Research, told USA Today, "There [is] no data to support wide use of remdesivir."
"This is extraordinary," he added, noting that there "seems to be a pattern of approval without science, without data, without evidence."
Francisco Marty, an infectious disease doctor and researcher at Brigham & Women's Hospital and Harvard Medical School who has helped conduct clinical trials on remdesivir, said he believes the expanded EUA will allow providers to use the drug to treat patients with less-severe cases of Covid-19 who are likely to benefit from the drug.
But Nuala Meyer, a critical care physician and scientist at the Perelman School of Medicine and the Hospital of the University of Pennsylvania, said she doesn't think the EUA will change the way she treats most of her Covid-19 patients. She explained that most of her current Covid-19 patients require hospital stays of about 48 hours, so it wouldn't be practical to treat them with remdesivir, which requires a five-day intravenous treatment course.
Further, Meyer said that, at PennMed, doctors treat Covid-19 patients with remdesivir only if they have pneumonia and require supplemental oxygen. "I'm not aware of a whole lot of data in hospitalized patients who don't require oxygen," she said.
As such, Meyer told USA Today that she was surprised by FDA's expanded EUA for remdesivir to treat all hospitalized patients with Covid-19. "We always expect the FDA to base decisions on data and we do get concerned when we see decision-making that we can't find the data to support," she said (New York Times , 8/31; Higgins-Dunn, CNBC, 8/29; Shumaker, Reuters, 8/30; Wilkerson, Inside Health Policy, 8/28 [subscription required]; Axelrod, The Hill, 8/28; Erman/Roy, Reuters, 8/28; Weintraub, USA Today, 8/29; FDA EUA, 8/28; FDA release, 8/28; New York Times , 8/31).