FDA Rejects Request to Authorize COVID-19 Treatment

A request by the U.S. Food and Drug Administration to approve a COVID-19 drug for patients in hospital has been rejected.

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 stated this in a statement.

Veru anticipates that the FDA will provide feedback soon about the proposed Phase 3 design.

A Panel Voted against Drugs

When considering authorization requests, FDA frequently consults its advisory panels. One of the panels met in 2022 and voted 8–5 to recommend the FDA not authorize sabizabulin.

Members voting against the drug voiced concern over the scale of the research used in the decision. Only 210 people were included in the study, and only 70 patients 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 University of California Irvine Department of Statistics) was one of the members that voted no 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 said that another member voted for it.

Members expressed the hope of another large-scale study that would then be done, and after that, it could be reexamined.

‘Disappointed’

Veru officials expressed disappointment at 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,” In a statement, Dr. Mitchell Steiner stated that he was the chairman, president and CEO.

“We will work closely with the FDA to gain clarity on advancing our sabizabulin program toward a potential new request” He added the authorization.

The decision to approve the drug is still being considered by regulators in Australia and Europe.