Many are anticipating that the US Food and Drug Administration (FDA) is going to announce its decision on Wednesday in authorizing the use of the antiviral drug remdesivir for coronavirus patients. This follows after the Gilead Sciences helped more than half of 397 patients relying on oxygen to leave the hospital in two weeks.
Gilead Sciences' results suggested that the drug could help fight the infection in patients to breathe on their own, although its approval is not yet secured from the FDA. Meanwhile, the National Institutes of Health director, Anthony Fauci said that the results are 'very optimistic.'
He also said that the trials the NIH has been doing have resulted in 8% of the remdisivir group dying compared to 11% of the placebo group.
"Mischaracterization" of results
Fauci not only called the findings of the trial a 'very optimistic' result, but he also noted that the drug 'could block the virus,' and even compared it to the previous result of the first antiretrovirals that work against HIV in the 1980s.
Despite this success, Fauci admitted that he has no timeline yet of FDA's schedule on approving the medication. The New York Times reported that the approval could be as early as Wednesday. Remdisivir will be the third drug approved under the EUA by the FDA after the agency approved anti-malaria drugs chloroquine and hydroxychloroquine.
The World Health Organization leaked last week that remdisivir had failed to help patients in a more than 200-person trial recover. Despite this, the drug is still among the top contenders of existing drugs under trial for treating COVID-19.
Gilead described the leaked data as a "mischaracterization" of the results in defense of the trial.
On Wednesday, they announced that the study produced 'positive data' for treating coronavirus patients after more than half of their test subjects have improved within ten days of a five-day treatment course, and those who were on a 10-days regimen were already feeling better by the eleventh day.
Due to this positive result, Dow announced that their points soared more than 500 points, although Gilead's stocks were stopped pre-trading as it prepared to announce the results of the trial.
Gilead's SIMPLE trial
Gilead is planning to take the testing into the next stage of its SIMPLE trial to be participated by 5,600 patients at 180 locations. This includes the US, the UK, China, France, Germany, Hong Kong, Italy, Japan, South Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, and Taiwan.
These trials will include patients who rely on mechanical ventilation to survive and will compare two treatment regimens-5- and 10-day courses- to those given standard supportive care. They hope to report the initial results of the trial by the end of May.
Timing also mattered in the study. Those who were treated early within ten days of the first onset of their symptoms fared better, with 62% discharged already from the hospital within two weeks.
These results bring light to how treatment with remdisivir may be optimized if it is proven safe and effective. However, more data are still needed before anything else.
