FDA rejects Humanigen’s EUA for COVID-19 drug

Sept. 9, 2021

Despite early signs that Humanigen was on track to win an emergency use authorization for its potential COVID-19 treatment, its hopes have been derailed by an FDA rejection.

This week, the agency denied Humanigen Inc.’s  application for an EUA for lenzilumab, a monoclonal antibody being trialed for its potential in preventing a cytokine storm —  a hyperinflammatory immune response that can impact patients with severe COVID-19. 

Late-stage study results from earlier this year made the prospects for the drug’s approval soar. According to one phase 3 trial that involved 520 patients hospitalized with COVID-19, the drug improved the rate of survival without a ventilator by 54%.

But the FDA could not be swayed. In its rejection, the agency said that the apparent benefits of the treatment do not seem to outweigh the risks, the company said.   

Humanigen said that it plans to submit additional data from another ongoing trial. Regulators in the U.K. have also started a rolling review of the drug.