US FDA backs Forest and Almirall's Tudorza Pressair to treat COPD

US drugmaker Forest Laboratories (NYSE: FRX) and Spain’s largest pharmaceutical firm Almirall (ALM: MC), which originated the drug, said yesterday that the US Food and Drug Administration has approved their Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

The decision comes after an earlier hitch, despite an FDA advisory panel 12 to two vote to recommend the drug (The Pharma Letter February 24), when the FDA said it will require a three-month extension to complete its review of the data supporting the New Drug Application for aclidinium bromide (TPL March 30).

COPD is a serious lung disease that makes breathing difficult. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States. Symptoms can include chest tightness, chronic cough, and excessive phlegm.