9 Sept 2021
FDA Declines Emergency use of Humanigen's COVID-19 Drug
The Index Today
The U.S. Food and Drug Administration announced that they declined Humanigen Inc's request for emergency use authorization (EUA) of the lenzilumab drug to treat newly hospitalized COVID-19 patients.
The company said in a statement that it was unable to conclude that the known and potential benefits of lenzilumab surpass the known and potential risks of its use as a treatment for COVID-19.
Humanigen Inc expects to have an ongoing study to provide additional safety and data of effectiveness to support its request of EUA.
Humanigen also started the process of UK authorization for the lenzilumab drug last June through a rolling review submission.