Humanigen said Sept. 9 that the FDA has denied emergency authorization of its monoclonal antibody drug lenzilumab for treatment of newly hospitalized COVID-19 patients.
In March, the Burlingame, Calif.-based drugmaker said that COVID-19 patients in a phase 3 clinical trial who received lenzilumab were 54 percent more likely to survive without needing ventilation over a 28-day period compared to patients who received a placebo.
In its letter denying authorization of the drug, the FDA said it was unable to conclude that the known and potential benefits of the drug outweigh the known and potential risks of its use as a COVID-19 treatment. The drugmaker didn't specify what the risks are.
Humanigen said another clinical trial led by the National Institutes of Health is expected to release further data on the drug that may support a new request for emergency use authorization.
"We remain committed to bringing lenzilumab to patients hospitalized with COVID-19," Cameron Durrant, MD, Humanigen's CEO, said in a news release.
Read the full news release here.