The US Food and Drug Administration has declined Humanigen Inc's request for emergency use authorisation (EUA) of its Lenzilumab drug to treat newly hospitalised Covid-19 patients, Reuters reports.
"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.
