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FDA approves Forest-Almirall’s Tudorza Pressair as treatment for COPD

Will compete with Boehringer and Pfizer’s Spiriva

The US Food and Drug Administration (FDA) has approved Forest Laboratories and Almirall's Tudorza Pressair (aclidinium bromide inhalation powder) as a long-term maintenance treatment for patients with bronchospasm.

Bronchospasm is the narrowing of the airways in the lung and is associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The drug enters a COPD market in the US that contains several existing treatments and Forest will face competition from Boehringer Ingelheim and Pfizer's Spiriva, both of which are inhaled drugs used to open airways.

Other potential competitors include inhaled steroids such as AstraZeneca's Symbicor and GlaxoSmithKline's Advair, which is soon to lose patent protection.

Forest has been affected by patent expiries too, having recently lost exclusivity for antidepressant Lexapro, so will be hoping that Tudorza Pressair will make up for this loss.

Tudorza is a twice-daily inhaled long-acting anticholinergic, also known as a long-acting muscarinic antagonist (LAMA). It provides treatment by inhibiting acetylcholine's effect on muscarinic receptors in the smooth muscle tissue of someone's airway.

COPD is a collection of common, progressive and debilitating lung disorders where a persistent airflow limitation makes it difficult to breath. Over 3 million people worldwide died of the condition in 2005, with cigarette smoking the leading cause. Symptoms can include chest tightness, chronic cough, and excessive phlegm.

Forest remarked that “as the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option”.

25th July 2012

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