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

RIDGEFIELD, Conn., Jan. 29, 2013 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended that clinical data included in a new drug application (NDA) provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. If approved by the FDA, it is anticipated that olodaterol will be marketed under the brand name Striverdi Respimat in the United States.

"We at Boehringer Ingelheim are pleased with the Advisory Committee's recommendation and look forward to continuing to work with the FDA as the Agency continues its review of the olodaterol NDA," said Tunde Otulana , MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.  "The positive vote from the Advisory Committee marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the United States."

The Committee also voted affirmatively that data showed the efficacy and safety of olodaterol supports approval of the 5 microgram dose. 

The Committee reviewed data from the Phase 3 olodaterol clinical trial program, including data from the 48-week and 6-week duration trials. These data are part of the NDA being reviewed to establish that olodaterol delivered once daily at the 5 microgram dose showed improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo and also active comparators.

The trials were conducted in a patient population represent
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SOURCE Boehringer Ingelheim
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