FDA on Thursday approved Gilead Sciences's antiviral drug remdesivir to treat hospitalized adults and children older than 12 with Covid-19, making remdesivir the first FDA-approved drug to treat Covid-19. The agency previously issued an emergency use authorization (EUA) allowing providers to use the drug to treat patients with severe cases of the disease.
US new coronavirus cases top 8.4M, deaths surpass 223K
The approval comes as U.S. officials as of Friday morning reported a total of 8,455,200 cases of the novel coronavirus since the country's epidemic began—up from about 8,378,700 cases reported as of Thursday morning.
According to the New York Times, the United States' average daily number of newly reported coronavirus cases over the past week was 62,166—which is up by 32% when compared with the average from two weeks ago. On Thursday, U.S. officials reported about 75,049 new cases of the virus, the Times reports.
Data from the Times shows that the rates of newly reported coronavirus cases are "staying high" in Guam and 33 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arkansas, Colorado, Florida, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, and Wyoming.
Seven states that have had comparatively low case rates are now seeing those rates "going up," according to the Times. Those states are Arizona, Connecticut, Georgia, Massachusetts, New Hampshire, New Jersey, and Pennsylvania.
In the 13 remaining U.S. states and territories, rates of newly reported coronavirus cases are "staying low," according to the Times' analysis.
U.S. officials as of Friday morning also reported a total of 223,023 deaths linked to the coronavirus since the country's epidemic began—up from about 222,157 deaths reported as of Thursday morning. According to the Times, officials reported at least 828 new deaths linked to the virus on Thursday.
FDA approves Gilead's remdesivir as the first Covid-19 treatment
As the numbers of novel coronavirus cases and related deaths continue to rise, researchers have been scrambling to discover a treatment for Covid-19, the disease caused by the virus.
Gilead's remdesivir, which is sold as Veklury, quickly emerged as one of the most promising experimental treatments for Covid-19, and FDA earlier this year issued an EUA allowing providers to use the drug to treat patients with severe cases of the disease. Since FDA issued the EUA for remdesivir, President Trump and thousands of other patients who have become infected with the novel coronavirus have taken drug as part of their treatment, Politico reports.
On Thursday, FDA fully approved remdesivir to treat patients hospitalized with Covid-19 who are at least 12 and weigh at least 88 pounds. For hospitalized Covid-19 patients under the age of 12, FDA said it will continue to allow providers to use remdesivir in certain circumstances under the drug's EUA.
However, there are limitations on the drug's use and administration: Under the approval, remdesivir "should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care," FDA said in release on Thursday. In addition, before patients can begin taking remdesivir, they must undergo certain kidney and liver tests to ensure the drug is safe for them and to monitor for potential side effects, according to the Associated Press. The drug's label also cautions providers against prescribing remdesivir with hydroxychloroquine, as it can reduce remdesivir's efficacy.
According to AP, a typical treatment course of remdesivir costs $2,340 for patients covered by Medicaid and other government health programs in the United States and $3,120 for those with private health plans. The actual amount patients pay out-of-pocket varies by their coverage and other factors, AP reports.
Approval decision
According to AP, FDA approved remdesivir based on data from three randomized, controlled clinical trials involving patients hospitalized with mild-to-severe cases of Covid-19. The data showed remdesivir, which works by inhibiting a substance the new coronavirus uses to replicate itself, could speed up recovery times and decrease the likelihood that Covid-19 patients would require supplemental oxygen.
For example, the results of a double-blind clinical trial led by the National Institute of Allergy and Infectious Diseases found that hospitalized Covid-19 patients who received remdesivir recovered from the disease in an average of 10 days—five days faster than patients who received a placebo. According to the researchers, the data also suggested that remdesivir may prevent Covid-19 patients from developing more severe cases of the disease and requiring more oxygen or ventilation.
However, none of the data from the clinical trials showed remdesivir could reduce the risk of death, Politico reports.
Meanwhile, according to Politico, FDA as part of the approval also issued Gilead a priority review voucher to accelerate the review of another drug. Gilead can use the voucher itself or sell it to another drugmaker. Remdesivir qualified Gilead for the voucher because the drug is considered a medical "countermeasure to a material threat—in this case, the virus," Politico reports.
Reaction
Some observers found FDA's approval puzzling since interim data from the World Health Organization released in a preprint study last week showed remdesivir had "little or no effect on mortality" among hospitalized patients with Covid-19.
Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said, "It's striking that a full approval happens right after we hear about data from the WHO trial that remdesivir has little effect in hospitalized patients."
Eric Topol, director of the Scripps Research Translational Institute, said he does not "think the data supports" FDA's approval, citing the results of WHO's trial.
However, FDA pushed back against the criticism. FDA in an FAQ released Tuesday said the clinical trial led by NIH "was better suited to rigorously assess a time to recovery endpoint" and that the results of the WHO trial "do not refute" the data from the trial led by NIAID.
Likewise, Merdad Parsey, Gilead's CMO, in an open letter Thursday wrote that the data from the WHO trial "does not negate other study results."
According to Politico, FDA's approval of remdesivir may prevent FDA from issuing EUAs for other Covid-19 treatments for hospitalized patients since the agency is only allowed to grant EUAs when there is no approved therapy for a condition.
However, Rachel Sachs, an associate professor of law at Washington University in St. Louis, said she believes that's unlikely since "the legal standards … leave room for more authorizations, especially for products that have different mechanisms of action or indications" (Brennan, Politico, 10/22; Lienhard, Inside Health Policy, 10/22 [subscription required]; Marchione, Associated Press, 10/22; FDA release, 10/22; FDA approval letter, 10/22; New York Times, 10/23).