Gilead's coronavirus treatment already had an FDA emergency authorization. Now it has an approval.
Good afternoon, readers.
We’ve written extensively about the emerging therapeutics against the coronavirus. One of the earliest contenders was remdesivir, an antiviral from biotech giant Gilead. It’s not a save-all; but it did just score a coveted distinction as the first Food and Drug Administration (FDA) approved treatment to tackle COVID-19.
Up until this point, remdesivir (which will now carry the brand name Veklury) was under an “emergency use authorization” that can significantly cap its market reach. Now, according to the FDA, it’s been approved outright “for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds).”
“Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the
United States.”
Gilead CEO Daniel O’Day reflected those comments in his own statements. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” he said.
The practicality of how that will work out is a different issue. Gilead’s drug is meant for the sickest patients and those who have been hospitalized. While the approval presents progress, it’s going to take a lot more time to determine what this means for the health of Americans at large.
Gilead’s stock was up more than 3 percent after hours.
Read on for the day’s news, and see you next week.
Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy
