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The U.S. Food and Drug Administration ( FDA ) has fully approved remdesivir as a treatment for COVID-19 .
The drug is now approve for use of goods and services in hospitalized COVID-19 patients 12 years old and up , and weighing at least 88 pounds ( 40 kilograms ) , according to astatement from the FDA . Previously , the agency allowed physician to give remdesivir to hospitalized patients through an emergency economic consumption authorization , or irregular license only given " when there are no passable , approve and available alternatives,“according to the agency .
Remdesivir shows promise in treating patients with severe COVID-19.
Now , ground on data from three clinical visitation , the FDA has travel to fully okay remdesivir . The approval is " substantiate by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milepost in the COVID-19pandemic , " FDA Commissioner Dr. Stephen Hahn pronounce in the statement . Hospitalized patient who weigh between about 8 pounds and 88 pound ( 3.5 - 40 kilograms ) or who are under 12 years old can still receive remdesivir under emergency use dominance , at their Dr. ’s discretion ; clinical trials for this group are still ongoing , the FDA noted .
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However , despite being the first FDA - approved COVID-19 drug in the U.S. , remdesivir is n’t a highly effective treatment , Dr. Megan Ranney , an associate professor of emergency medication and public health at Brown University in Rhode Island , toldBuzzFeed News .
" It is absolutely not a blockbuster drug or a miracle drug , " Ranney told BuzzFeed . " We give it to hospitalize COVID patients because we do n’t have anything good , which is frustrative . "
" This is not a blockbuster drug , " echoed Dr. Peter Lurie , a former associate commissioner with the F.D.A. and now Chief Executive of the Center for Science in the Public Interest , in an interview withThe New York Times . " This is not some monumental breakthrough . It ’s a drug that appear convincingly to do good patients , but it ’s not some kind of miracle cure . "
In the trial the FDA expect at , remdesivir reduced patient role ' symptom more quickly than standard care alone and significantly bowdlerise patients ' infirmary stays , harmonise to the program line . In one trial that include more than 1,000 patient , those who received the drug spend about five fewer days in the infirmary than those who didn’t , Live Science previously reported .
That said , a recent test convey by the World Health Organization contradicts these convinced finding , Live Science antecedently report . The run , which included more than 11,200 people from 30 land , find that remdesivir did not importantly shorten affected role ' fourth dimension in the infirmary , nor did it lose weight the risk of being come in on a ventilator . And most significantly , the drug did not increase patients ' hazard of endurance , according to the trial solution .
But the WHO trial has not yet been peer - reviewed , and it has drawn some critical review from investigator since being posted online .
The WHO tryout took blank space at 405 unlike hospital around the world , and patient ' attention may have differed between the many locations , Dr. Peter Chin - Hong , an infectious diseases expert at the University of California , San Francisco , told The Times . Differences in care could potentially bear on patient selection and make the effect of remdesivir difficult to rally out . Also , some of the tryout participants were sicker than others across group , making it difficult to secern if the drug works well in one group over another , BuzzFeed reported .
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In addition , Gilead Sciences , the company that produces remdesivir , argued that the WHO field of study could be somewhat biased because both the doctors and patients eff which drug were being used , Reuters reported . In other words , the trial was not " blinded , " which would be considered the golden standard for a clinical run .
Whether it helps or not , remdesivir comes with a muscular cost shred compared with bum treatments being tested for COVID-19 , such as thesteroiddexamethasone . A five - day course of remdesivir costs $ 3,120 , or $ 2,340 for government emptor like the Department of Veterans Affairs , Reuters report . Dexamethasone , meanwhile , costs less than $ 1 per day for treatment on a single patient role , according to the Times . In add-on , as need for the drug soar worldwide , the global supply of remdesivir has fallen poor , BuzzFeed report .
Originally designed to treat Ebola and hepatitis C , remdesivir works by mimicking a nucleotide , one of the molecular building cylinder block that make out together to build viral genes , Live Science antecedently reported . This molecular mimicker can pass through thegenetic materialof the coronavirus and stop it from infecting electric cell . Most patient role stomach the discourse well , meaning inauspicious side effects are fairly uncommon , Ranney told BuzzFeed .
Originally published on Live Science .
