United States FDA gave the green light on the emergency use of the experimental drug remdesivir on Friday that appears to help some coronavirus patients recover faster.
It is the first clinically tested drug shown to help combat the novel Coronavirus disease, which has killed more than 230,000 people worldwide.
The FDA said in a statement that Gilead Science's "remdesivir" would be specifically indicated for hospitalized patients with "severe disease," such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
United States President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O'Day and Food and Drug Administration Commissioner Stephen Hahn.
The FDA acted after preliminary results from a government-sponsored study showed that the drug, remdesivir, shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.
The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir's effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average vs. 15 days for the comparison group.
The FDA said that performance warranted Friday's decision, though regulators acknowledged "there is limited information known about the safety and effectiveness of using remdesivir."
"The drug's side effects include potential inflammation of the liver, which could lead to nausea, vomiting, sweating and low blood pressure. Fact sheets about dosing and potential safety issues will be provided to physicians and patients," the FDA said.
The National Institutes of Health's Dr. Anthony Fauci said Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. The drug, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with less severe illness.
The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.
Follow the latest news on Google News
