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FDA Committee Recommends Approval of Olodaterol for Maintenance Treatment of COPD

Inhaled drug designed for use in combination with tiotropium (Jan. 30)

The FDA’s Pulmonary–Allergy Drugs Advisory Committee has recommended the approval of the investigational compound olodaterol (Boehringer Ingelheim) as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The committee’s recommendation was based on results from a phase III clinical trial program, which included data from 48-week and 6-week trials. The findings showed that olodaterol 5 mcg once-daily improved lung function, as measured by the forced expiratory volume in 1 second (FEV1), over at least 24 hours in patients with moderate to very severe COPD compared with placebo and active comparators.

Overall, olodaterol was well tolerated. The most commonly reported adverse reactions were nasopharyngitis, dizziness, rash, and arthralgia. The patients were allowed to continue with their usual care, with the exception of long-acting beta agonists. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids, and xanthenes.

Olodaterol, delivered in an inhaler, is designed to be used in combination with tiotropium for maintenance treatment of COPD.

COPD is a major cause of death and disability throughout the world. As the disease progresses, lung function declines, and physical activity may become severely limited.

The World Health Organization (WHO) estimates that 210 million people have COPD worldwide. According to the WHO, more than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that COPD will become the third leading cause of death worldwide by 2030.

Source: Boehringer Ingelheim; January 30, 2013.

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