UB research played a part in Remdesivir's road to approval for COVID treatment

Oct 23, 2020

The Food and Drug Administration has approved a drug for use in the treatment of hospitalized COVID-19 patients. Remdesivir's road to approval was paved by numerous institutions researching the drug, including the University at Buffalo's Jacobs School of Medicine and Biomedical Sciences.

Remdesivir, which was created by Gilead Sciences and sold under the name Veklury, works by inhibiting a substance which allows a virus to make copies of itself. It was first developed in 2009 as a means to treat hepatitis C. It didn't work out as developers had hoped, but it show some promise as a treatment which could weaken and kill the Ebola virus.

Credit CDC Image Library / Centers for Disease Control and Prevention

This spring, the federal government granted permission to use remdesivir on an emergency basis. University at Buffalo researchers began clinical trials on emergency patients in April. Data collected from UB's tests were later shared with other researchers who were conducting randomized trials.

"This was the one treatment where we have, now, a placebo controlled randomized trial, you know, the right way to do it, where we had the appropriate control to actually measure the effect of the medication, and be confident that it's worked," said Dr. Sanjay Sethi at UB's Jacobs School. "I think we have the confidence, that we had the right kind of data with this drug to use it, and that's where the FDA approved it."

Studies show Remdesivir shortened recovery times by, on average, about five days. It's administered intravenously. The FDA's approval is for use of the drug in hospitalized COVID patients ages 12 or older.

Research continues, not just on Remdesivir but on other treatments including convalescent plasma. Dr. Sethi, acknowledging the COVID fatigue felt by the general public, warns against rushing too quickly to develop treatments, as well as a vaccine. Acquiring the right evidence is important, he says, noting the early attention placed on hydroxychloroquine. Even convalescent plasma, he added, has come under question by a paper recently published by researchers in India.

"The last thing we want is a situation where you have a vaccine, which is not fully tested, and then you discover adverse effects later," he said. "The adverse effects are not going to be zero, but they have to be something which is acceptable and manageable."

Prevention remains the most important strategy now is prevention, until scientists can get the body to produce its own antibodies.