The U.S. Food and Drug Administration (FDA) has declined emergency use authorization for a lenzilumab monoclonal antibody drug to treat COVID-19, according to the developer of the drug. Humanigen sought emergency use authorization for the medication to treat newly hospitalized COVID-19 patients. The company filed its petition with the drug regulator in May. “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,” the Burlingame, California-based firm said in a statement. The head of Humanigen, Cameron Durrant, said that the company plans to keep trying to develop the drug. “We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an [emergency use authorization] to treat hospitalized COVID-19 patients,” he said. COVID-19 …
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