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Dr. The drug was given so-called fast track status by the Food and Drug Administration in January, Steiner said. The identification aims to enable faster development and review of new treatments that address unmet medical needs and target serious or life-threatening conditions.
Dr. Steiner said the company plans to meet with the agency later this month and will apply for an emergency use permit for sabizabulin. An FDA spokesperson declined to comment, saying the agency did not approve, reject, or comment on pending applications.
Company officials said that no safety concerns regarding the drug were identified during the clinical trial.
“Despite two and a half years at war, we’re still working hard to add highly effective drugs to the mix to treat this particular patient population, and that’s a pretty dramatic improvement in 60-day death rates,” he said. Michael Gordon is a trial investigator and chief medical officer at the HonorHealth Institute for Research and Innovation in Scottsdale, Arizona.
However, Dr. Gordon left his optimism cautiously, saying he’d like to see more detailed analysis. Additional data were still being analyzed Monday, including the proportion of patients treated without respiratory failure, the number of days spent in intensive care, length of hospital stay and how long they were on mechanical ventilation.
Dr. “No drug works for everyone,” Gordon said. “The benefit seen isn’t mortality – who lives and who dies – who leaves oxygen, I predict we’ll see improvements in other parameters as well.”
Patients in both arms of the multicenter trial received all standard care and treatment. Participants were in the United States, Brazil, Argentina, Mexico, Colombia, and Bulgaria and were infected with both Delta and Omicron variants. Dr. Gordon and company officials said the drug is effective regardless of the variant type.
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