FDA in talks with Gilead to make remdesivir available to coronavirus patients ‘as quickly as possible’

The Food and Drug Administration has been in “sustained and ongoing” discussions with Gilead Sciences to make antiviral drug remdesivir available to Covid-19 patients “as quickly as possible, as appropriate,” the agency said Wednesday.

Earlier in the day, White House health advisor Dr. Anthony Fauci said data from a coronavirus drug trial testing Gilead’s drug showed “quite good news” and sets a new standard of care for Covid-19 patients.

Speaking to reporters from the White House, Fauci said he was told data from the trial showed a “clear-cut positive effect in diminishing time to recover.”

The New York Times reported that the FDA plans to announce as early as Wednesday an emergency use authorization for remdesivir.

FDA spokesman Michael Felberbaum told CNBC, “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.”

President Donald Trump has touted Gilead’s 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 studies are testing the drug to see if it’s effective in stopping the coronavirus from replicating, but it is not yet a proven treatment. 

Gilead also released Wednesday preliminary results from its own study, showing at least 50{3c4481f38fc19dde56b7b1f4329b509c88239ba5565146922180ec5012de023f} of the patients treated with a five-day dosage of remdesivir improved. The clinical trial involved 397 patients with severe cases of Covid-19. 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.