The Food and Drug Administration (FDA) has declined the Emergency Use Authorization request for lenzilumab for the treatment of hospitalized patients with COVID-19.
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody. The EUA application included data from the phase 3 LIVE-AIR trial (ClinicalTrials.gov Identifier: NCT04351152), which assessed whether the use of lenzilumab in addition to current standard of care could alleviate immune-mediated cytokine release syndrome and improve ventilator-free survival in hospitalized patients with severe or critical COVID-19 pneumonia.
According to an FDA letter sent to Humanigen, the request for emergency use was declined because the Agency “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 is expected to provide further data to the FDA from the NIH’s ongoing phase 2 ACTIVE-5/BET-B trial (ClinicalTrials.gov Identifier: NCT04583969), which is assessing the effect of lenzilumab on survival without ventilation in adults hospitalized with COVID-19.
“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,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen.
FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for lenzilumab in hospitalized COVID-19 patients. News release. Humanigen, Inc. September 9, 2021. Accessed September 13, 2021.https://www.businesswire.com/news/home/20210908006189/en/FDA-has-declined-Humanigen%E2%80%99s-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients.