The Food and Drug Administration has approved remdesivir to treat COVID-19 in hospital patients The drug, manufactured by pharmaceutical company Gilead, is the first COVID-19 treatment approved in the United States
Remdesivir, now marketed under the brand name Veklury, was cleared for emergency use by the FDA in May This emergency clearance indicated that the FDA believed the benefits of using the drug outweighed the risks, although there was no clear evidence to show that it was helping COVID-19 patients at the time
« The FDA is committed to accelerating the development and availability of COVID-19 treatments during this unprecedented public health emergency, » FDA Commissioner Stephen Hahn said in a statement
The drug works by preventing viruses from reproducing It was first developed by Gilead to treat Ebola, and research in recent years has shown that it can prevent the SARS and MERS coronaviruses from spreading replicate inside cells This is why scientists have turned to this new coronavirus
In recent months, remdesivir has become part of the standard treatment for COVID-19 patients at many hospitals in the United States Treatment benefits appear limited Clinical trials of the drug show that it may help some patients recover faster, but cannot prevent death from the disease
Most clinical trials have given remdesivir to sicker patients, who may not see the drug’s greatest benefit – because it stops the virus from replicating, it might be more effective sooner in a person’s illness, before the virus spreads their body
Since the release of the first data in the spring, experts have said the treatment would likely have a small effect on patients It is not a panacea, although it could be beneficial In April, Anthony Fauci, director of the ‘National Institute of Allergy and Infectious Diseases, said it « does not appear to be a 100% knockout », but it could block the virus
I’m not surprised From the start I said that Remdesivir is a good shot but not a home run
The FDA has certain limits on the drug It is only approved for inpatients and is not yet approved for children under the age of 12 The FDA noted in its review that there was still not good data on how the medicine would affect children, pregnant women or anyone with kidney or liver problems There is also no good data on drug interactions. “These limitations result, in part, from the important public health priority of accelerating the review of safe and effective treatment in the context of unmet medical need, ”the agency wrote Gilead will need to do further research to answer these questions
Compared to the normal drug approval process, FDA approval of remdesivir has happened very quickly.The speed at which this particular treatment has been tested and approved shows the importance of early investment in research outside of an emergency The only reason remdesivir was able to enter clinical trials so soon after the pandemic began was because of the fundamental work of the scientists who have studied the drug over the past decade.
Gilead will continue to study remdesivir and is currently conducting studies testing the drug in children and patients with COVID-19 who are not hospitalized The company’s medical director said in an open letter it will have sufficient doses to treat « all clinically appropriate patients in the world » by next week
News from the world – United States – FDA approves remdesivir to treat COVID-19
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