The Food and Drug Administration has approved remdesivir to treat hospitalized covid-19 patients. The antiviral drug, which is manufactured and sold by the pharmaceutical company Gilead under the brand name Veklury, is the first to be approved for treating the virus in the U.S.
The FDA authorised remdesivir for emergency use in May, indicating at the time that the benefits of the drug outweighed the potential risks. Large-scale treatment trials by the World Health Organisation have since indicated that remdesivir has “little or no effect” on death rates of hospitalized covid-19 patients.
Nonetheless, the FDA announced its approval on Thursday for adults and children over the age of 12 (provided they meet certain weight restrictions) who have been hospitalized by the virus.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” said FDA Commissioner Stephen M. Hahn in a press release. “As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to[sic] continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
In its decision, the FDA cited two studies sponsored by Gilead, one of which showed that taking remdesivir slightly improved symptoms among adult patients with covid-19, though not by a statistically significant rate, while the other showed it didn’t make much of a difference at all. A third study the agency cited conducted by the National Institute of Allergy and Infectious Diseases found that remdesivir slightly decreased recovery time for patients. So while it’s far from the kind of panacea President Donald Trump has touted in the past for other experimental covid-19 treatments, some patients could see benefits from taking the drug.
First developed by Gilead to treat Ebola, remdesivir works by disrupting a virus’s replication process and keeping it from multiplying. Research has shown that it can be used to block the activity of coronaviruses in cells, and it has been found effective against other strands like MERS and SARS. Dr. Anthony Fauci, the nation’s leading infectious disease expert, said in April that trials had shown the drug modestly improved the recovery times of covid-19 patients.
The improvement “doesn’t seem like a knockout 100 per cent,” Dr. Fauci said in a White House press briefing at the time, but “it is a very important proof of concept, because what it has proven is that a drug can block this virus.”
Gilead will continue conducting research on remdesivir, as the FDA notes in its research that there’s still a lack of sufficient data about how the drug affects children under 12 years old, people who or pregnant, or people with underlying health conditions. In an open letter published Thursday, Gilead’s chief medical officer said that the company is fast-tracking production and will have enough doses to treat “all clinically appropriate patients globally” by next week.
And as with everything in America’s busted healthcare system, this treatment isn’t going to be cheap. In June, Gilead announced that it’s charging private insurance companies $US520 ($732) per vial of the drug. A patient undergoing a typical five-day treatment course usually receives six vials, the company said, thus putting the total per patient treatment cost at $US3,120 ($4,389) for those with private insurance plans. What that translates into in terms of out-of-pocket costs is dependent on the patient’s specific plan and insurance provider, a Department of Health and Human Services official told CNBC. In short: Who the fuck knows.
Given the timing and the fact that the FDA OK’d remdesivir ridiculously quickly compared to its usual drug approval processes, my money’s on this being a White House bid to secure a treatment ahead of November’s presidential election. It would not surprise me at all if, a few weeks from now, we’re seeing headlines about how Trump officials thumbed the scales in some quasi-legal attempt to give him material to flaunt in the face of “Sleepy Joe.”