On Nov. 9, an FDA committee voted 8-5 against Veru Pharma’s sabizabulin, deciding the risks outweigh the potential benefits, according to a news release from the drugmaker. Veru submitted an emergency use authorization application in June for sabizabulin to be intended to treat hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome.
The FDA will make a final decision based on the panel’s discussion.
On Nov. 10, the FDA authorized Swedish Orphan Biovitrum’s Kineret (anakinra) for emergency use to treat hospitalized COVID-19 adults with pneumonia who require supplemental oxygen and are at risk of progressing to severe respiratory failure. Sobi, which is based in Stockholm, said in a news release the medication’s authorization was an “important milestone.”
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