It’s not a done deal. But so far, all indications point to the probability of Veru, a small biotech, winning the latest Emergency Use Authorization from the FDA for a COVID-19 treatment. And if all goes well, the approval would be the first of its kind for a company of its size — potentially catapulting Veru from relative obscurity into a blockbuster drugmaker.
Here’s how it happened.
The company announced in April that it was halting a late-stage trial for sabizabulin, an antiviral and anti-inflammatory treatment in hospitalized COVID-19 patients, because the drug was so successful in reducing deaths, it would not have been ethical to continue giving other patients a placebo.
On May 10, Veru was then granted a pre-EUA meeting with the FDA to discuss filing for the approval. According to Veru’s CEO, Mitchell Steiner, the tone of the meeting was unlike others he’s had with the agency.
“They’ve seen the data. The safety is there, the efficacy is there,” he explains. “So this was more like they were saying ‘Tell us about your drug supply because we have to get this going.’ It was very process-oriented.”
The reason for the rush is that although vaccines have made an enormous impact on the fight against COVID-19, and other therapies have been shown to reduce symptoms or speed recovery, the death rate for hospitalized patients has remained stubbornly high. But in the trial of severely ill patients with COVID-19 at high risk for acute respiratory distress syndrome (ARDS), sabizabulin reduced the chance of death to about 20%, compared to 45% on a placebo.
And of course, the pandemic hasn’t been “behaving,” Steiner notes. Despite the many mitigation efforts, COVID-19 has continued to mutate and spread — presenting an ongoing challenge made all the more apparent recently when the U.S. passed the grim milestone of 1 million COVID-related deaths.
“If our drug would have been available at the start of the pandemic, 500,000 patients would be home right now,” Steiner says.
Veru plans to submit its materials for the EUA by the end of this quarter and expects to hear back from the FDA within two months of submission.
Now, Veru is hustling to quickly scale up for widespread distribution.
