AstraZeneca's Fasenra (benralizumab) Fails Ph III Trial for COPD

AstraZeneca and MedImmune, announced on 5/11/18 top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD.

Dr. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”

Fasenra was approved in 2017 for severe eosinophilic asthma. This was the first approval for AstraZeneca's respiratory biologics portfolio.

Fasenra (benralizumab) is a monoclonal antibody that recruits natural killer cells to induce rapid and near-complete depletion of eosinophils, a type of white blood cell that are a normal part of the body’s immune system. Depletion of circulating eosinophils is rapid, with an onset of action within 24 hours as confirmed in Phase I/II severe asthma trials.