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Posted On: 03/03/2023 12:53:02 PM
Post# of 148878
The FDA has rejected a Covid-19 drug over uncertainties around a small trial. I know we have moved on from Covid (at least at the present time), but I thought some points in this article would be of interest: the drug had been tested in cancer; the Covid trial was stopped early because of clinical benefit; and the study included 204 Covid patients. Just another example of how hard it is to get FDA approval, especially with regard to safety concerns.
Following the advice of a panel of outside experts, the FDA has turned down a potential Covid-19 drug that only had data from a small trial.
Miami, FL-based Veru had repurposed a microtubule disruptor called sabizabulin, which it had been testing in cancer, to treat hospitalized adult patients with moderate to severe Covid-19 who are at high risk for ARDS, or acute respiratory distress syndrome.
CEO Mitchell Steiner suggested that the FDA rejected the drug “because of the possibility of unknown influences, or uncertainties that may have affected the study.” The company noted that the agency offered comments for a proposed confirmatory Phase III.
To support its EUA, Veru submitted data from 204 patients hospitalized with Covid. It stopped the trial early because of clinical benefit.
In briefing documents prepared ahead of an advisory committee, the FDA had spelled out its concerns with the pivotal data that Veru submitted. It acknowledged that sabizabulin hit the mark on mortality in the small trial, but noted uncertainties or imbalances that, while not problematic individually, “raise questions about the results.”
FDA’s Pulmonary-Allergy Drugs Advisory Committee generally offered support, with some qualms, on the survival data. Yet when it came to recommending an OK, the adcomm members largely argued that there weren’t enough safety and efficacy data, understanding of the drug was still limited, and that the demonstrated benefits don’t outweigh the risks. Voting 8 to 5 against its authorization, many asked for a new trial.
Veru said it remains committed to developing sabizabulin for the high-risk patient population, and added that the drug is under regulatory review in other countries.
https://endpts.com/fda-rejects-covid-19-drug-...all-trial/
Following the advice of a panel of outside experts, the FDA has turned down a potential Covid-19 drug that only had data from a small trial.
Miami, FL-based Veru had repurposed a microtubule disruptor called sabizabulin, which it had been testing in cancer, to treat hospitalized adult patients with moderate to severe Covid-19 who are at high risk for ARDS, or acute respiratory distress syndrome.
CEO Mitchell Steiner suggested that the FDA rejected the drug “because of the possibility of unknown influences, or uncertainties that may have affected the study.” The company noted that the agency offered comments for a proposed confirmatory Phase III.
To support its EUA, Veru submitted data from 204 patients hospitalized with Covid. It stopped the trial early because of clinical benefit.
In briefing documents prepared ahead of an advisory committee, the FDA had spelled out its concerns with the pivotal data that Veru submitted. It acknowledged that sabizabulin hit the mark on mortality in the small trial, but noted uncertainties or imbalances that, while not problematic individually, “raise questions about the results.”
FDA’s Pulmonary-Allergy Drugs Advisory Committee generally offered support, with some qualms, on the survival data. Yet when it came to recommending an OK, the adcomm members largely argued that there weren’t enough safety and efficacy data, understanding of the drug was still limited, and that the demonstrated benefits don’t outweigh the risks. Voting 8 to 5 against its authorization, many asked for a new trial.
Veru said it remains committed to developing sabizabulin for the high-risk patient population, and added that the drug is under regulatory review in other countries.
https://endpts.com/fda-rejects-covid-19-drug-...all-trial/
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