Two months ago, virtually no one had heard of remdesivir. But now the antiviral drug is on people's lips around the world — including Dr. Anthony Fauci's. The nation's top infectious disease specialist says the experimental treatment can help some seriously illmore quickly. And that's raising a host of questions about the medication, ranging from its clinical benefits to its potential cost.
Remdesivir (pronounced rem-des-eh-veer) is an antiviral medication developed by the pharmaceutical giant Gilead Sciences, which originally developed it to treat Ebola and other deadly viruses. Preliminary data from an international COVID-19 drug trial "shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Fauci told reporters at the White House on Wednesday.
Still, experts say remdesivir is likely to play only one part in the broader public health response to the coronavirus, while its commercial importance to Gilead remains to be determined, even as enthusiastic investors drove up its stock price nearly 10% in recent days.
"We've characterized remdesivir as an important part of the public health solution," said Jim Birchenough, a Wells Fargo analyst who covers Gilead Sciences. "There are hundreds of trials going on evaluating other therapeutics. We think this could be just the beginning."
So what exactly is remdesivir? Read on.
What did the drug trial find?
The drug trial, which involved over 1,000 hospitalized patients in the U.S., Germany, Denmark, Spain, Greece and other countries, reduced recovery time for COVID-19 patients from 15 days to 11 days, Fauci said. The drug works by stopping the replication mechanism of the coronavirus.
"Although a 31% improvement [in a lengthy recovery time] doesn't seem like a knockout 100%, it is a very important proof of concept," Fauci said, noting that "what it is proving is that a drug can block this virus."
The test evaluated the drug's effects on patients in serious condition. Another trial will look at remdesivir's impact on people with moderate cases of the disease. Gilead said it expects results from that effort by the end of May.
Is the excitement warranted?
In the trial cited by Fauci, patients given remdesivir had a slightly lower mortality rate, 8% compared to 11%, but that was not enough to be considered statistically significant in the study. Fauci said more research will be needed.
"That's important because it's lives saved, but it doesn't save 50%," said Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner with the U.S. Food and Drug Administration. "Remdesivir isn't a game changer, but it is a positive."
What is Gilead Sciences known for?
Gilead is known chiefly for its HIV and hepatitis treatments. The company has also been the focus of accusations of price gouging. The Trump administration last year sued Gilead for earning billions from research backed by taxpayer funding without paying back the support, as well as infringing on patents owned by the U.S. Department of Health and Human Services.
Is remdesivir approved by the FDA?
No, although a spokesman for the Food and Drug Administration said the agencywith Gilead about possibly using remdesivir to fight COVID-19.
"As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," the FDA spokesman said in a statement to CBS News.
The FDA could decide to authorize emergency use of drug, Pitts said. While that step wouldn't constitute full approval by the agency — a formal move that indicates a drug has been proven safe and effective — it would at least allow doctors to use the drug at their own discretion. Given the absence of any approved treatments for COVID-19, that could potentially help patients.
How much will it cost?
That's unclear, although Gilead has vowed to initially offer remdesivir without charge, according to Wells Fargo's Birchenough.
"They said they can make 1.5 million doses right now, which could treat 280,000 patents on a five-day course, and they are going to donate those doses," he said. "The initial indication is that Gilead is doing the right thing from a public health perspective."
Several key questions remain, including how Gilead would distribute the drug outside the U.S. and how it might be priced down the road.
Public health experts and investors are also watching other developments in the fight against COVID-19.
"Over the next few months, we should get more data from immune-modulating drugs that reduce the immune system reaction that can prove fatal" to COVID-19 patients, Birchenough said. "There are antibody cocktails that are being evaluated, and then obviously we have thethat will start to generate data over next few months."