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US FDA panel votes against Veru’s COVID-19 pill

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, Aug 29, 2020. (ANDREW KELLY / REUTERS)

NEW YORK / LONDON / MOSCOW – A panel of outside advisers to the US health regulator on Wednesday voted against authorizing Veru Inc's 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.

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While data shows sabizabulin can also produce antiviral and anti-inflammatory responses, the US Food and Drug Administration staff reviewers have said its effects against COVID-19 are uncertain.

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.

United Kingdom

More than three quarters of British people who have suffered persistent ill health following a COVID-19 infection have had to cut back or change the work they do, according to a survey on the impact of long COVID published on Wednesday.

The survey of 1,002 people, conducted by market research company Censuswide in Oct for recruitment website Indeed, adds to signs that long COVID continues to be a factor behind widespread labor shortages in Britain.

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Some 98 percent of long COVID sufferers said the condition had limited their ability to work, 78 percent had needed to cut back or change their work and 19 percent had ceased work altogether.

Russia

Russia has registered 5,335 new COVID-19 cases in the past 24 hours, taking the nationwide tally to 21,477,926, said the official monitoring and response center on Wednesday.

The center said the nationwide death toll increased by 62 to 390,774, while the number of recoveries grew by 8,492 to 20,876,892.