FDA Encourages Veru to Submit EUA Application for COVID-19 Therapy

In the wake of strongly positive data and an FDA go-ahead, Veru will seek an Emergency Use Authorization (EUA) for sabizabulin, its investigational COVID-19 therapy.

An Independent Safety Data Monitoring committee halted sabizabulin’s pivotal phase 3 trial last month after determining that the drug decreased the risk of death by 55 percent in patients hospitalized for moderate-to-severe COVID-19 (DID, April 13).

Veru then went on to regulatory talks with the FDA and the agency said the data were good enough to support the efficacy portion of an EUA request and a New Drug Application submission as well, the company said.

The agency also told the company that the safety data so far also support an EUA. However, an NDA would need additional safety data. If the EUA is granted, those data can be collected during sabizabulin use. No additional new clinical study would be necessary in that case, the agency said.

The company plans to submit a request for an EUA next quarter. It’s already scaled up manufacturing and said it will be able to “produce commercial drug supply to address anticipated drug needs following potential FDA authorization and subsequent authorizations in the U.S. as well as other countries and regions.”

Veru expects the drug to be quite lucrative. The company is already in discussions with national and international governments to arrange purchases.

“We expect to have significant near-term revenue from sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, if EUA is granted by U.S. FDA,” said Mitchell Steiner, Veru’s chief executive officer. — Michele G. Sullivan