AstraZeneca COPD drug combination approved in EU

AstraZeneca's (AZ) Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation (MA) by the European Commission (EC) for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

The drug combination is part of the Almirall respiratory franchise that AZ took over earlier this month, paying $875 million upfront, and up to a further $1.22 billion in development, launch and sales-related milestones.

Although AZ has a long heritage in respiratory medicine, it has not produced any new products in the field for some time and faces pressure from generics for its blockbuster combination treatment Symbicort, which earned the company $3.4 billion in 2013, so this approval marks a step in the right direction for patients and shareholders.

Duaklir is a fixed-dose combination of already-approved Eklira (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair dry powder inhaler device.

Aclidinium bromide works by inhibiting the muscarinic M3 receptor in the airway smooth muscle, while Formoterol fumarate stimulates the β2-receptors in the bronchial smooth muscle resulting in bronchodilation.

Approximately 300 million people around the world live with COPD, a progressive and chronic disease where people find breathing difficult due to limited airflow. Improving the lung function and managing daily symptoms such as breathlessness are important to the management of COPD.

Duaklir Genuair provides physicians and patients a choice of products uniquely available in both dry powder and pressurised metered dose devices.

The EU approval was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide. The MA applies to all member states of the EU and the European Economic Area.

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AstraZeneca completes takeover of Almirall respiratory franchise