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FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD
Date:1/29/2013

ative of those seen in clinical practice. The most commonly reported adverse reactions were nasopharyngitis, dizziness, rash, and arthralgia. Patients involved in the studies were allowed to continue on their usual care with the exception of long-acting beta agonists. Usual care included anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthenes.

Full results from the Phase 3 studies included in the olodaterol NDA will be presented at a future medical meeting.

In addition to the 48-week and 6-week duration studies assessing the safety and efficacy of olodaterol, the Committee also reviewed a set of replicate studies evaluating the impact of olodaterol on exercise tolerance in COPD patients. This is the first time a company has sought inclusion of exercise tolerance data in a COPD product's label.

"Patients with COPD often have impaired exercise tolerance because lung hyperinflation develops during exercise," said Richard Casaburi , PhD, MD, Professor of Medicine, UCLA School of Medicine. "Improving exercise tolerance is a critical component of COPD management strategies."

About COPD
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 24 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the third leading cause of death in the United States. It kills one person every four minutes in the United States.

Common symptoms of COPD include coughing with or without excess mucus or shortness of breath.

Leading respiratory forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people liv
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