It’s the first full approval for a drug treating the disease.
The Food and Drug Administration (FDA) approved remdesivir to treat COVID-19 in hospitalized patients. The drug, manufactured by the pharmaceutical company Gilead, is the first approved COVID-19 treatment in the United States, the Verger reported.
Remdesivir, now marketed under the brand name Veklury, was authorized for emergency use by the FDA in May. That emergency authorization indicated that the FDA thought the benefits of using the drug outweighed the risks, even though there was no clear evidence showing that it helped patients with COVID-19 at the time.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn in a statement.
The drug works by preventing viruses from making copies of themselves. It was first developed by Gilead to treat Ebola, and research over the past few years showed that it could block the coronaviruses SARS and MERS from replicating inside cells. That’s why scientists turned to it for this new coronavirus.
For the past few months, remdesivir has been part of the standard treatment for COVID-19 patients in many hospitals in the US. The benefits of the treatment appear to be limited. Clinical trials of the drug show that it may help some patients recover more quickly, but that it may not prevent death from the disease.
Most clinical trials have given remdesivir to the sickest patients, who may not see the biggest benefit from the drug — because it stops the virus from replicating, it could be more effective earlier on in someone’s illness, before the virus has spread through their body.
Ever since the initial data was released in the spring, experts have said that the treatment would probably have a small effect on patients. It’s not a cure-all, even though it could be beneficial. In April, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said it “doesn’t seem like a knockout 100 percent,” but it could block the virus.
The FDA does have some limitations on the drug. It is only approved for hospitalized patients, and it’s not yet approved for children under 12 years old. The FDA noted in its review that there still wasn’t good data on how the drug would affect children, people who are pregnant, or anyone with kidney or liver issues. There also isn’t good data on interactions between drugs. “These limitations result, in part, from the important public health priority of expediting the review of a safe and effective therapeutic in the setting of an unmet medical need,” the agency wrote. Gilead will be required to do additional research to answer those questions.
Compared to the regular drug approval process, the FDA’s approval of remdesivir happened very quickly. The speed at which this particular treatment was tested and approved shows the importance of early investment in research outside of an emergency. The only reason that remdesivir was able to head into clinical trials so soon after the pandemic began was due to the foundational work from scientists studying the drug over the past decade.
According to the Verge, Gilead will continue to study remdesivir and is now running studies testing the drug in children and in COVID-19 patients who are not hospitalized. The company’s chief medical officer said in an open letter that it would have enough doses to treat “all clinically appropriate patients globally” by next week.
By Nicole Wetsman