AstraZeneca COPD drug wins EU marketing approval
AstraZeneca said its Trixeo Aerosphere had been given marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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The Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on results from a Phase III trial in which Trixeo Aerosphere “showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere and PT009 over 52 weeks”, the company said on Monday.
Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD, it added.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384m people and is the third leading cause of death globally.
In a separate statement, AstraZeneca said its Forxiga (dapagliflozin) treatment had been recommended for an indication extension of its marketing authorisation in the EU for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without type-2 diabetes.