FDA is considering whether to grant Gilead Sciences' remdesivir an emergency use authorization to treat patients with severe cases of Covid-19, after NIH on Wednesday released preliminary data from a closely watched clinical trial suggesting the drug may help patients recover from the disease faster.
US Covid-19 cases surpass 1M, death toll tops 60K
The news comes as the number of cases of Covid-19 and deaths tied to the new coronavirus continues to grow. As of Thursday morning, U.S. officials had reported 1,045,300 cases of Covid-19 in the country—up from 1,012,683 cases as of Wednesday morning.
Officials as of Thursday morning also had reported 60,945 U.S. deaths linked to the new coronavirus—up from 53,034 deaths reported as of Wednesday morning.
Preliminary data shows remdesivir sped recovery in patients with severe cases of Covid-19
NIH in a release issued Wednesday said an analysis of preliminary data from its randomized controlled trial evaluating remdesivir as a possible treatment for Covid-19 found hospitalized patients with advanced Covid-19 and lung involvement who were treated with remdesivir recovered from the disease faster than those who received a placebo.
The clinical trial, which is sponsored by NIH's National Institute of Allergy and Infectious Diseases (NIAID), began Feb. 21 and involves 1,063 patients. However, Elizabeth Hohmann, a physician who enrolled 49 patients in the trial at Massachusetts General Hospital, explained that the data analysis released Wednesday is based only on data from "the first cut of 460 patients" who participated in the trial.
The analysis of the trial's preliminary data showed that patients with severe cases of Covid-19 who received remdesivir had an average recovery time of 11 days, while patients with severe cases of Covid-19 who received a placebo had an average recovery time of 15 days. Put another way, the press release stated that patients who were treated with remdesivir had a 31% faster recovery time on average than patients who received the placebo.
In addition, the preliminary results showed patients with severe cases of Covid-19 who were treated with remdesivir had lower mortality rates than those who received a placebo. According to the preliminary data, the mortality rate among patients who received remdesivir was 8%, compared with a mortality rate of 11.6% among those who received a placebo.
According to the Associated Press, the preliminary findings represent the first signs of a potential treatment to improve the outcomes of patients with Covid-19.
NIAID Director Anthony Fauci during a White House briefing on Wednesday said the preliminary findings show remdesivir could modestly accelerate recovery times for patients with Covid-19. He said the improvement in recovery times "doesn't seem like a knockout 100%," but the preliminary findings represent "a very important proof of concept, because what it has proven is that a drug can block this virus."
Fauci noted that while the preliminary data shows patients who took remdesivir had lower mortality rates than their counterparts, the difference was not statistically significant. He also noted that the preliminary findings haven't yet been peer reviewed.
Still, Fauci said he is optimistic that remdesivir will become "the standard of care" for Covid-19 patients. He added that other potential Covid-19 treatments now will need to be tested against remdesivir.
FDA explores authorizing remdesivir for emergency use to treat severe Covid-19 cases
According to the Wall Street Journal, FDA is exploring whether to make remdesivir more widely available by granting the drug emergency use authorization to treat patients with severe cases of Covid-19.
Gilead CEO Daniel O'Day said the company is in active discussions with FDA about receiving the emergency authorization. "I know [FDA is] working in earnest to determine the path forward and make the decision," he said. "It's full-steam ahead with this new clinical data in hand now."
If FDA approves an emergency use authorization for remdesivir, Gilead would be allowed to work with the federal government to directly ship the drug to hospitals with the greatest need for a Covid-19 treatment, O'Day said.
Former FDA Commissioner Scott Gottlieb said the preliminary data from the NIH trial should provide FDA with enough evidence to issue the emergency use authorization. "Remdesivir isn't a home run but looks active and can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall," he said.
Experts caution remdesivir is not a 'silver bullet' for the Covid-19 epidemic
While the NIH trial's preliminary results show promise, public health experts are flagging that remdesivir hasn't been show to cure Covid-19, explaining that the initial results showed patients who were treated with the drug had a faster recovery than patients who received a placebo—but not a complete recovery.
"Remdesivir is a real drug for" Covid-19, but "not a silver bullet," Umer Raffat, a pharmaceutical analyst at Evercore ISI, wrote Wednesday in a note to investors.
Further, other studies have produced conflicting data on remdesivir's effectiveness for treating Covid-19. For example, a separate study published in The Lancet, which was stopped because of recruitment issues, found remdesivir did not provide Covid-19 patients with significant benefits when compared with a placebo.
In addition, the World Health Organization (WHO) last week accidentally published a draft summary of results of a clinical trial that suggested remdesivir did not benefit most patients with Covid-19 and indicated that remdesivir was linked to side effects in Covid-19 patients. The draft also indicated that more patients who were treated with remdesivir died when compared with patients who were not treated with the drug—though the mortality differences were not statistically significant.
WHO quickly deleted the clinical trial results from its website, and Gilead spokesperson Sonia Choi said the results were "inconclusive" because the study ended early. Choi said Gilead felt "the post included inappropriate characterization of the study" and that "trends in the data suggest[ed] a potential benefit for remdesivir, particularly among patients treated early in disease."
Overall, experts say it's too early to tell whether remdesivir could be an effective treatment for Covid-19 without full data from the NIH trial.
Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania who wasn't involved in the remdesivir studies, said, "We have these … studies coming out … and they're all different." She added, "I do think the NIAID results are going to be the most reliable, but until we actually see the results as opposed to the summary, it's hard to say" (Herper/Feuerstein, STAT News, 4/29; Kolata et al., New York Times, 4/29; Marchione, Associated Press, 4/29; Edwards, NBC News, 4/29; Owermohle, Politico, 4/29; NIH release, 4/29; Walker, Wall Street Journal, 4/29; Herper, STAT News, 4/29; Owens, "Vitals," Axios, 4/30; Lapid, Reuters, 4/29; New York Times, 4/30 ; New York Times, 4/30 ).