The U.S. Food and Drug Administration (FDA) said on Wednesday it has been in “sustained and ongoing” talks with Gilead Sciences to make antiviral drug remdesivir available to coronavirus patients “as quickly as possible, as appropriate.”
Earlier in the day, Dr. Anthony Fauci, White House health advisor, said data from a coronavirus drug trial testing Gilead’s remdesivir showed “quite good news” and sets a new standard of care for the coronavirus patients.
Fauci told reporters from the White House that he was told data from the drug trial showed a “clear-cut positive effect in diminishing time to recover.”
U.S. President Donald Trump has touted the anti-malarial remdesivir as a potential treatment for the virus, which has infected more than 3.1 million people worldwide, according to data compiled by Johns Hopkins University. A number of clinical trials are being conducted on the drug to see determine its effectiveness in stopping the coronavirus from replicating, but it is not yet a proven treatment.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.” FDA spokesman Michael Felberbaum told CNBC.
Earlier in the day, Gilead released preliminary results from its own study, showing at least 50 percent of the patients treated with a five-day dosage of remdesivir improved. The clinical trial involved 397 patients with severe cases of the virus. However, it said the severe study is “single-arm,” meaning it did not evaluate the drug against a control group of patients who didn’t receive the drug.
