The U.S. Food and Drug Administration (FDA) has rejected a request to authorize a drug as a COVID-19 treatment for hospitalized patients.
Florida-based Veru said March 2 that the FDA informed the company it would not grant emergency use authorization (EUA) for sabizabulin, the drug.
Veru asked in 2022 for authorization for the drug as a treatment for hospitalized adults with moderate to severe COVID-19 who were deemed high risk for Acute Respiratory Distress Syndrome, a lung condition that proves fatal in some cases.
“In communicating its decision, the FDA stated that despite the FDA declining to issue an EUA for sabizabulin at this time, the FDA remains committed to working with the Company for the development of sabizabulin,” Veru said in a statement.
The FDA also provided feedback on a proposed Phase 3 study design and Veru expects to provide details about the study soon.
The FDA regularly consults with its advisory panels when considering requests for authorization. One of the panels met in 2022 and voted 8–5 to recommend the FDA not authorize sabizabulin.
Members who voted against the drug said they were concerned about the size of the study on which the application was based. It included just 210 patients, 70 of whom received a placebo.
“I do think that given the small trial size, that there could be easy shifts in these things, depending upon what the baseline severity of disease might have been or any potential differences could have come through in the patient population,” Daniel Gillen, chancellor’s professor and chair in the department of statistics at University of California, Irvine, and one of the members who voted no, said during the meeting. “So because of that, my enthusiasm is certainly tempered.”
“I simply don’t feel we have enough data, but feel that this has enough promise to deserve a future study,” Jennifer Schwartzott, another member, who voted for the drug, said.
Members expressed hope that another, larger study would be conducted, after which the matter could be revisited.
Veru officials said they were disappointed with the FDA’s decision.
“We are disappointed in the FDA’s decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study,” Dr. Mitchell Steiner, chairman, president, and CEO, said in a statement.
“We will work closely with the FDA to gain clarity on advancing our sabizabulin program toward a potential new request” for authorization, he added.
Regulators in Europe and Australia are still weighing whether to clear the drug.