FOSTER CITY (CBS SF/AP) — Foster City-based Gilead Sciences’ experimental drug — remdesivir — has been granted FDA approval for emergency use to help coronavirus patients make quicker recovery from infections.
It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide.READ MORE: Gov. Newsom Signs Executive Order to Halt Pandemic Evictions Through June
The Food and Drug Administration acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s 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.
- Fauci Calls Foster City-Based Gilead’s COVID-19 NIH Test Results ‘Quite Good News’
- Most COVID-19 Patients In Experimental Gilead Drug Trial Recovering Quickly
- Coronavirus Patients Rush To Join Studies Of Gilead Drug Remdesivir
President Donald Trump announced the FDA’s action at the White House.READ MORE: Armed Guards, Volunteers Join Police to Patrol Streets in Oakland's Chinatown
Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
The National Institutes of Health’s Dr. Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients like those in this study. The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.
Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more.
No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.MORE NEWS: Royals Week: Rare Archival Footage Of Princess Margaret's 1965 SF Visit Unearthed
The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after President Donald Trump repeatedly promoted it as a possible treatment for COVID-19. No large high-quality studies have shown the drug to work for that, however, and it has significant safety concerns.