About 70% of patients who received remdesivir for 10 days showed improvement.
Gilead Sciences Inc. reported on Monday that its antiviral drug remdesivir offers modest benefit to patients with moderate COVID-19 who received treatment for five days, while those who received the drug for 10 days in the study did not. did not come out as well.
Gilead’s shares fell about 4%.
Remdesivir, which is administered intravenously in the hospital, is the first drug to show improvement in COVID-19 patients in formal clinical trials, and new information on its effectiveness is being closely monitored worldwide, as countries are fighting the pandemic.
The advanced study of nearly 600 patients evaluated the safety and efficacy of a 5 and 10 day treatment with remdesivir in addition to standard care for people with moderate COVID-19 – the disease caused by the new coronavirus – compared to standard care alone.
On day 11, approximately 76% of patients in the 5-day treatment group showed improvement in clinical status versus 66% for standard care alone, said Gilead.
About 70% of patients who received remdesivir for 10 days showed improvement, “tending to but not reaching statistical significance,” said the drug manufacturer.
More detailed information on the study that Gilead did not provide on Monday, such as more information on patient demographics, is needed to explain the difference between the two treatment groups, according to doctors and analysts.
Remdesivir is under close scrutiny after the US Food and Drug Administration granted an Emergency Use Authorization (EUA) last month, citing the results of a study by the United States government that showed that the stay hospitalization reduced by 31%, or about four days, compared to a placebo.
The FDA did not immediately respond to a request for comment on whether to consider expanding the EUA, and Gilead told Reuters that it was in talks with the regulator to determine the appropriate patients to be treated in under authorization.
There is currently no US-approved treatment or vaccine for the new coronavirus that has infected more than 6 million people and killed nearly 373,000 people worldwide, including more than 104,000 dead in the United States. .
The drug has received approval from Japanese health authorities. U.S. approval requires a rigorous and lengthy FDA review, but the USA can be used in a health crisis when other options are not available.
Dozens of companies are working on a variety of treatment and vaccine approaches for the disease.
The drug, which had previously failed to treat Ebola, is designed to deactivate the mechanism by which certain viruses, including the new coronavirus, copy themselves and can potentially overwhelm their host’s immune system.
Infectious Disease Specialist Dr. Daniel McQuillen at Lahey Hospital & Medical Center in Burlington, Massachusetts, said it was difficult to draw a conclusion as to why patients in the shortest course outperformed those in the longest until the publication of complete data.
The results of the trial “confirm our anecdotal experience and that of others,” McQuillen said in an email. “The drug is promising in hospital patients treated early while the disease is still in its viremic phase,” which means the virus is circulating in a patient’s blood.
Jefferies analyst Michael Yee said the improvements were only modest.
“This is gradually adding to the wider use of the drug in a more moderate population inside the hospital, but the consensus already understands that remdesivir is not a quick fix,” Yee wrote in a research note. .
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)
