FDA declines Emergency Use Authorization (EUA) request for lenzilumab in hospitalized COVID-19 patients

In its letter, FDA stated 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. Company says ongoing ACTIV-5/BET-B trial may provide additional safety and efficacy data.

SPS commentary:

Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and ICU admission. Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. The company has submitted lenzilumab to MHRA for a rolling review towards potential Marketing Authorization.

Source:

Biospace Inc.