Posted by on September 9, 2021 3:01 pm
Categories: News

FDA Denies Emergency Use Approval to New COVID-19 Drug

The U.S. Food and Drug Administration (FDA) declined emergency use approval for a lenzilumab monoclonal antibody drug to treat COVID-19, according to Humanigen. Humanigen, the developer of the drug, sought the FDA’s emergency use authorization for the medication to treat newly hospitalized COVID-19 patients. The firm filed its petition with the drug regulator in May 2021. “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 company said in a statement. The head of Humanigen, Cameron Durrant, said that the company will attempt 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,” …

Originally appeared on The Epoch Times

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