FDA approves Gilead’s Veklury remdesivir for COVID-19

But.. the evidence is mixed.

The US Food and Drug Administration announced on 22nd October that it has approved the first COVID treatment, remdesivir. The drug is approved for patients over 12 years of age, weighing at least 40 kilograms. Only the patients who require hospitalization can be injected with the drug. Now marketed by the name Veklury, the drug was manufactured by the pharmaceutical company Gilead. The drug’s approval came after three randomized clinical trials were conducted, and the data showed favorable results. 

Gilead COVID

Veklury, the drug, was originally approved by the FDA in May 2020 for emergency use to speed up hospitalized patients’ recovery process. FDA indicated that the benefits of the drug outweighed its risks and that it speeds up the recovery after a trial from the National health institute. President Donald Trump was also given the same drug when he started showing symptoms earlier this month. However, this drug has limited benefits, and according to WHO research, it does not prevent death from COVID-19. 

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Stephen M. Hahn, the commissioner of FDA, said, “Today’s approval [Veklury] 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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will 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.”

How does Remdesivir work?

The drug works by preventing viruses from making copies of themselves by jamming itself into new viral genes. Gilead first developed it to treat the hepatitis C and Ebola virus, but recent research shows that it can fight the coronaviruses SARS and MERS from replicating inside cells. This is the reason why scientists started focusing on it. 

Remdesivir is being used as part of the COVID treatment for a few months now, and it has only shown limited benefits. Most trials were conducted on the sickest patients, but since it prevents virus replication, it would be more helpful to use it in the early stages instead. 

So the drug will only have a mild impact on the infected patients and cannot be termed as ‘the cure,’ but it will surely help in this fight against the pandemic.

The Limitations on the Veklury

The drug faces some limitations in terms of what patients can use due to the limited research conducted so far. FDA mentioned that it does not have data on how the Remdesivir would affect children, pregnant, or anyone with kidney or liver issues. There is also not enough research to tell how the interaction of remdesivir with other drugs would be, so people who take different medicines might be at risk too. Gilead agency wrote that “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.”

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Luckily, the scientists were already working on the drug for the past decade. Hence, the drug was moved towards clinical trials much sooner. The drug was tested and improved much faster compared to regular drug approval duration. This shows how important early research is. 

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Gilead is continuing its trial and research of remdesivir on children and on COVID patients who are not hospitalized to meet the limitations. According to Merdad Parsey’s statement, the company’s chief medical officer, they will have enough samples in a week to treat all clinically appropriate patients globally.

Featured image: Reuters

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