The federal Food and Drug Administration approved the first new treatment for COVID-19 October 22. Foster City-based Gilead Sciences' remdesivir, to be marketed as Veklury, was approved for adults and children age 12 and older who require hospitalization.
"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," FDA commissioner Dr. Stephen Hahn said in a statement Thursday. "Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic."
The FDA previously granted emergency use authorization for remdesivir for people hospitalized with severe COVID-19 in May, and expanded the EUA to include all hospitalized patients, regardless of disease severity, in August. A modified EUA remains in place for younger children.
Remdesivir, which is administered as an IV infusion, was one of the treatments President Donald Trump received during his bout with COVID-19 earlier this month.
Originally developed as a treatment for hepatitis C and Ebola virus, remdesivir is a nucleotide analogue, in the same class as several widely used HIV and hepatitis medications. It interferes with a viral enzyme and prevents viruses from making copies of themselves.
Clinical trials of remdesivir have yielded mixed results.
In a pair of studies sponsored by Gilead, hospitalized patients with moderate COVID-19 who used remdesivir for five days were about 65% more likely to experience clinical improvement than a standard of care group. About two-thirds of people with severe disease showed clinical improvement.
The National Institute of Health's ACTT-1 trial showed that hospitalized patients who received remdesivir recovered in 10 days, on average, compared with 15 days for those who received a placebo. Remdesivir also reduced the likelihood of being put on a ventilator or undergoing external blood oxygenation. There was a trend toward a lower risk of death (11% versus 15%), but the difference was not statistically significant.
Most recently, the World Health Organization's large Solidarity trial found that remdesivir did not reduce the risk of death, the chances of being put on a ventilator, or the length of hospitalization compared with standard care.
Some experts think remdesivir holds more promise for people treated earlier in the course of illness. Researchers are now testing remdesivir in combination with various other therapies, and are working on injected and inhaled formulations that would be more practical than IV administration for people treated outside a hospital.
"The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need," Dr. Barry Zingman of Montefiore Medical Center in New York City said in a Gilead news press release.
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