FDA Advisory Committee Recommends Approval of Tiotropium Respimat® for the Maintenance Treatment of COPD

Ridgefield, CT, August 14, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim’s investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva® Respimat®.

The Advisory Committee voted that existing data supports approval after a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium in the RESPIMAT device.  One of these trials, TIOSPIR™, the largest clinical trial conducted to date in patients with COPD, collected data from more than 17,000 COPD patients from 50 countries.

“As a practicing physician, it’s essential to have multiple treatment choices available when assessing how to help people affected by this devastating disease,” said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center.

The Advisory Committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval. 

“We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium RESPIMAT in the U.S.,” said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium RESPIMAT would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option.”

RESPIMAT is a multi-dose, propellant-free inhaler that uses mechanical energy to generate a slow-moving mist to deliver tiotropium, the same active ingredient as Spiriva® HandiHaler® (tiotropium bromide inhalation powder). If approved, tiotropium RESPIMAT would provide physicians and their patients with a choice between a mist and dry powder inhaler for tiotropium.

The availability and continued use of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is not affected by the Advisory Committee vote or subsequent FDA decision. SPIRIVA HandiHaler has an established efficacy and safety profile based on 29 clinical trials in over 12,000 patients.

About Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler is a prescription medicine used once each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations).

Important Safety Information for Spiriva HandiHaler (tiotropium bromide inhalation powder)
Do not use SPIRIVA HandiHaler (tiotropium bromide inhalation powder) if you are allergic to tiotropium or ipratropium (e.g., Atrovent®) or any of the ingredients in SPIRIVA HandiHaler. If your breathing suddenly worsens, your face, throat, lips, or tongue swells, you get hives, itching or rash, stop taking SPIRIVA HandiHaler and seek immediate medical help.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device.

If you have vision changes or eye pain or if you have difficulty passing urine or painful urination, stop taking SPIRIVA HandiHaler and call your doctor right away.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA HandiHaler. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA HandiHaler is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not let the powder from the SPIRIVA capsule get into your eyes.

Dizziness and blurred vision may occur with SPIRIVA HandiHaler. Should you experience these symptoms, you should use caution when engaging in activities such as driving a car or operating appliances or other machines.

Read the Patient Information and the step-by-step Instructions for Use for SPIRIVA HandiHaler before you use your inhaler.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.

Click here for full Spiriva Prescribing Information, Patient Information and Instructions for Use.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging.  COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

Leading respiratory forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

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 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales. 

For more information please visit http://www.us.boehringer-ingelheim.com.