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AstraZeneca's Fasenra fails 2nd phase 3 study in lung disease

AstraZeneca Plc said the second of two phase 3 studies of Fasenra in chronic obstructive pulmonary disease failed to meet its main goal.

Results from the trial, called Terranova, showed Fasenra failed to show a statistically significant reduction in exacerbations — the sudden worsening of symptoms — in patients with moderate to very severe chronic COPD.

The safety and tolerability findings in Terranova were consistent with those observed in previous trials of Fasenra. AstraZeneca said it is conducting a full evaluation of the data and does not plan to file a regulatory submission at present.

In May, the U.K. biopharmaceutical company announced that Fasenra failed to deliver statistically significant benefits to patients with COPD in the first phase 3 study, dubbed Galathea.

Fasenra, also known as benralizumab, is the drugmaker's first respiratory biologic and is approved as an add-on treatment for severe eosinophilic asthma in the U.S., the EU, Japan and several other countries. The results of the Galathea and Terranova trials do not affect the approved indication in severe eosinophilic asthma.

COPD is a progressive disease that can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects about 384 million people worldwide and is predicted to be the third-leading cause of death by 2020.

AstraZeneca developed Fasenra with its MedImmune unit and in-licensed the drug with Japan's Kyowa Hakko Kirin Co. Ltd.