FDA declines Humanigen Emergency Use Authorization for Lenzilumab in Hospitalized COVID

 

• FDA has committed to working with Humanigen in the development of lenzilumab and has invited Humanigen to submit additional data as it becomes available

• NIH’s ACTIV-5/BET-B study is expected to provide further data that may support a new EUA request

• Humanigen remains committed to completing regulatory processes underway seeking Marketing Authorization for lenzilumab to treat hospitalized COVID-19 patients in the U.K. and other territories

Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced today the U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. 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.

"We remain committed to bringing lenzilumab to patients hospitalized with COVID-19," said Cameron Durrant, MD, Chief Executive Officer, Humanigen. "We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients."

https://finance.yahoo.com/news/fda-declined-humanigen-emergency-authorization-041600134.html