AstraZeneca announced that the European Commission granted their lead drug, Duaklir® Genuair®, marketing authorization as a maintenance bronchodilator treatment for adult patients with chronic obstructive pulmonary disease.
Chronic obstructive pulmonary disease (COPD) is characterized by chronically poor airflow and frequently associated with emphysema (loss of alveolar surface area) and bronchitis (a condition where occurs inflammation of the mucous membranes of the bronchi). Disease severity escalates with time and was ranked as the fourth leading cause of mortality worldwide. In 2011, 13 million American adults were estimated to suffer from COPD according to The American Lung Association. Thus, improving patients symptoms is a key factor when managing COPD.
Duaklir is a combined therapy administered as a fixed dose of two previously approved drugs – Eklira® (aclidinium bromide) and formoterol. While the first is a long-acting muscarinic-antagonist (LAMA) that reverses airway obstruction by blocking the effects of acetylcholine on muscarinic receptors, the latter is a long-acting beta-agonist (LABA) that induces bronchodilation. This combined therapy is administered twice-a-day with an Genuair® dry powder inhaler device. It was shown to improve significantly the shortness of breath symptoms, when compared to individual treatments.
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Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca commented, “We are pleased to receive European regulatory approval for Duaklir Genuair as an innovative treatment for patients with COPD. Patients need treatments that can help to improve their lung function and allow them to manage better the daily and debilitating symptoms of their condition, in turn improving their overall quality of life.”
Duaklir® Genuair® approval by the European Commission was based on efficacy and safety clinical studies performed with more than 2000 patients recruited worldwide. The EC approval rants Astrazeneca marketing authorization in all member states of the EU and the European Economic Area.