Reuters-By Bhanvi Satija and Raghav Mahobe
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Nov 9 (Reuters) – A panel of outside advisers to the U.S. health regulator on Wednesday voted against authorizing Veru Inc’s (VERU.O) drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial.
The panel voted 8-5 against the oral drug sabizabulin’s usage and hinted that Veru gather additional data, preferably from a larger sample, regarding the drug’s ability to treat COVID-19.
“Even though (the data) is impressive for a new molecular entity – it has no direct evidence to support the antiviral activity,” said panel member Susanne May, who voted against authorization of the drug.
The unfavorable vote is a setback for Veru in its effort to develop a COVID-19 treatment. The company was originally testing sabizabulin, which prevents tumor cells from multiplying, as a treatment for prostate cancer.
While data shows sabizabulin can also produce antiviral and anti-inflammatory responses, the U.S. Food and Drug Administration staff reviewers have said its effects against COVID-19 are uncertain.
Veru’s application for authorization was based on data from a late-stage study of 210 patients, although the regulator had warned that this was small compared to other authorized drugs and proposed a 500-patient sample size.
During the meeting, other issues with sabizabulin’s data were also discussed, such as the lack of clarity over a relevant patient population and the high rate of deaths in a placebo group, which the reviewers had previously flagged.
“I feel that this (data) has enough promise to deserve a future study,” panel member and patient representative Jennifer Schwartzott said.
The FDA is not obligated to follow the recommendations of the panel, but usually does. If authorized, the pill would provide an additional treatment option as the disease moves from a pandemic to an endemic stage.
Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber
Our Standards: The Thomson Reuters Trust Principles.