AstraZeneca announced top-line results from the Galathea Phase III trial for Fasenra in patients with moderate to very severe chronic obstructive pulmonary disease. The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD. The safety and tolerability findings in Galathea were consistent with those observed in previous trials with Fasenra, the company said. It added, a full evaluation of the data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting. Fasenra is currently approved as an add-on treatment for severe eosinophilic asthma in the U.S., Europe Japan and several other countries. The results of the Galathea trial do not impact the approved indication in severe eosinophilic asthma, AstraZeneca said. Dr. Sean Bohen, the company’s Chief Medical Officer, added: “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.”
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