FDA Rejects Humanigen’s Lenzilumab for COVID-19

The FDA has declined to grant Humanigen an Emergency Use Authorization (EUA) for its antibody lenzilumab for treatment of hospitalized COVID-19 patients.

The agency instead sent the Burlingame, Calif.-based company a Complete Response Letter in which it said 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.

But the agency also said in the letter that it is committed to working with Humanigen to develop lenzilumab and has invited the company to submit additional data as it becomes available, the company said.

Humanigen CEO Cameron Durrant said the National Institutes of Health’s ACTIV-5/BET-B study, which is enrolling up to 500 patients, is expected to provide further data that may support a new EUA request.