The Food and Drug Administration has declined to grant emergency use authorization to lenzilumab, an experimental drug developed by Humanigen, for the treatment of hospitalized patients with Covid-19, the company said Thursday.
“In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,” Humanigen said.
The decision highlights a problem that has plagued drug development during the pandemic: Too many clinical trials were run in populations so small that it has been difficult to draw conclusions about the risks and benefits of medicines because there is too much uncertainty around results.
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