FDA Approves Remdesivir As A Coronavirus Treatment

The Food and Drug Administration has approved remdesivir as the first drug to treat Covid-19. This was announced in a press release on the health agency’s website.

The drug has been approved for both children and adults above the ages 12 years old and who weigh at least 40 kilograms or 88 pounds. The drug can only be used by people who have been hospitalized for Covid-19, the disease caused by the coronavirus.

This new move signals the confidence of the government in the drug as a treatment option for coronavirus infection that has killed more than 220,000 people in the United States.

Before this, FDA had granted the drug an emergency authorization in May, when it was shown that the drug can reduce hospital stay in COVID-19 patients. The drug was given to President Trump as well, when he was diagnosed with coronavirus infection just this month.

One important thing to note here is that remdesivir does not prevent death in COVID-19, as shown by a World Health Organization study of 11,000 people from 30 countries. However, the approval suggests that the drug has cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.

“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” Dr. Stephen M. Hahn, the agency’s commissioner, said in a statement. “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.”

In one randomized, placebo and double-blind study funded by the National Institute of Allergy and Infectious Diseases, it was seen how long did the patients, who took the drug, recovered. Out of 1062 people who were hospitalized with coronavirus, 541 were given Veklury (remdesivir) and 521 acted as control.

Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The drug reduced the time of recovery by four days in people on the drug, compared to those on the placebo. The odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.

In another randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19, it was seen that being on the drug for 5 days provided significant therapeutic benefit. Same benefit was also seen in a third and separate trial. If you are interested to read up on these trials, the details are available in the official press release.

Initially, remdesivir was developed as a treatment for Ebola and hepatitis C. The drug works by interfering with the reproduction of viruses. It does so by incorporating itself into new viral genes.

The drug however was not approved by and advisory committee of experts outside FDA. Dr. Peter Lurie, a former associate commissioner with the FDA and now president of the Center for Science in the Public Interest, explained that it was normal.

“The F.D.A. tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness,” Dr. Lurie said. “This is not a blockbuster drug. This is not some massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.”

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