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FDA Gives COVID Drug with Memphis Ties Fast-Track to Emergency Use


Veru Inc., a company with deep ties to Memphis, has received the green light to seek permission from the FDA for fast-track emergency approval of a drug that more than cut in half deaths of people hospitalized for serious respiratory issues caused by COVID.

To speed up the process, the FDA will not require Veru to provide further safety or efficacy studies of sabizabulin beyond the findings already presented from the Phase III clinical trial, which was stopped April 8 because it would be unethical to continue giving the placebo.

The sabizabulin molecule was created at the University of Tennessee Health Science Center and later with Ohio State University when a key researcher moved there.

It works by collapsing the pathways — microtubules — through the cell, limiting, in the case of COVID, the virus’s ability to replicate itself and move the daughter cell out to infect the next cell.

It works similarly in cancers. In the case of prostate cancer, the microtubules allow androgen hormones to be transported through the body, fueling the fire.

By allowing Veru to use safety and efficacy data from the Phase III trial, the FDA is shaving off precious time to get the drug to market, said Dr. Duane Miller, one of the researchers who worked on the drug molecule.

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