LONDON (dpa-AFX) - AstraZeneca Plc.(AZN.L, AZN) said that late-stage ETHOS trial for triple-combination therapy Breztri Aerosphere met its primary endpoint in chronic obstructive pulmonary disease or COPD.
Breztri Aerosphere has been approved in Japan and is under regulatory review for approval in China, where it has been granted Priority Review by the National Medical Products Administration. It is also under review in the US and EU.
As per the terms of the agreement to acquire Pearl Therapeutics Inc., AstraZeneca anticipates making a $150m milestone payment upon US regulatory approval of Breztri Aerosphere for COPD. This payment would be the final development and regulatory milestone under that agreement.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness
Separately, AstraZeneca said announced that the US Food and Drug Administration has granted Orphan Drug Designation to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis.
eosinophilic oesophagitis is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the oesophagus causing injury and inflammation.
Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd., Japan.
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