FDA Advisory Committee Recommends Approval for Boehringer Ingelheim’s Olodaterol for Maintenance Treatment of COPD

Ridgefield, CT, January 29, 2013 – 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.

“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 5µg 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 µg 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 representative 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 living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. Subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

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