US FDA Declines Emergency Use Approval for Humanigen's COVID-19 Drug

By Reuters Staff

September 10, 2021

(Reuters) - The U.S. Food and Drug Administration declined Humanigen Inc's request for emergency use authorization (EUA) of its lenzilumab monoclonal antibody drug to treat newly hospitalized COVID-19 patients, the company said on 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," the company said in a statement.

Humanigen expects an ongoing study to provide additional safety and efficacy data to support its new EUA request.

The company filed its application with the FDA for emergency use of the drug in May, citing late-stage trial data.

Humanigen also started the process of UK authorization for the drug in June through a rolling review submission.