FDA Approves Boehringer Ingelheim’s SPIRIVA RESPIMAT for the Maintenance Treatment of Asthma in Adults and Adolescents

RIDGEFIELD, Conn., September 16, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily, prescription maintenance treatment of asthma in people ages 12 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

Asthma, which affects more than 22 million people in the U.S., can cause a patient’s airways to become inflamed and tighten, making it hard to breathe. Despite currently available treatments, many patients continue to experience asthma symptoms, which can have a negative impact on their ability to perform daily activities. One survey found 55 percent of people with asthma taking at least one treatment still experienced symptoms.

The approval of SPIRIVA RESPIMAT establishes a new class of asthma medication known as long-acting muscarinic antagonists (LAMAs). SPIRIVA RESPIMAT is steroid-free and works differently than a long-acting beta2 agonist (LABA). When asthma symptoms persist despite taking a daily maintenance treatment, adding SPIRIVA RESPIMAT may help people breathe better and reduce attacks (also known as exacerbations).

“In my clinical experience, some patients with uncontrolled asthma, despite treatment, continue to experience symptoms, which can include coughing, wheezing, waking at night or shortness of breath,” said Dr. William Busse, Professor of Medicine, Division of Allergy, Pulmonary and Critical Care, at the University of Wisconsin School of Medicine and Public Health. “For patients who continue to experience these symptoms, SPIRIVA RESPIMAT is a once-daily maintenance treatment that has been shown to provide additional bronchodilation to help patients breathe better and reduce asthma attacks.”

The FDA approved SPIRIVA RESPIMAT based on efficacy and safety data from a comprehensive clinical trial program, including 12 trials of approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma on at least an inhaled corticosteroid (ICS). Data from this clinical program showed that the addition of SPIRIVA RESPIMAT significantly improved lung function, as measured by forced expiratory volume in one second (FEV₁ AUC_0-3hr and trough FEV₁) and reduced exacerbations for asthma patients, compared to placebo. An asthma exacerbation was defined as a progressive increase in asthma symptoms* or a decrease in a patient’s best morning peak expiratory flow (PEF) that required treatment with systemic steroids for at least three days.

The safety profile of SPIRIVA RESPIMAT in asthma was demonstrated across the clinical trial program. The most common side effects (>2% incidence in the placebo-controlled trials with treatment durations between 12 and 52 weeks) were sore throat, sinus infections, bronchitis, and headache in adults.

SPIRIVA RESPIMAT is now approved at two different doses. For asthma, the FDA approved a once-daily dose of 2.5 µg (delivered in 2 puffs of 1.25 µg each). SPIRIVA RESPIMAT is also approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) as a once-daily dose of 5 µg (delivered in 2 puffs of 2.5 µg each) for the maintenance treatment of COPD. Both doses for SPIRIVA RESPIMAT should be taken as 2 puffs once daily.

Tiotropium, the active ingredient in SPIRIVA, has been used for more than 10 years as a maintenance treatment for COPD and has extensive clinical experience with over 40 million patient-years.  

“For nearly a century, Boehringer Ingelheim has been dedicated to discovering medicines for serious respiratory diseases, such as asthma,” said Sabine Luik MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “As an industry leader in respiratory, it is our goal to develop new medicines that help address unmet needs. This FDA approval enhances asthma therapy by providing healthcare providers and patients with a new class of treatment to consider.”

*Shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms

About the RESPIMAT Inhaler
The RESPIMAT is the platform inhaler for the Boehringer Ingelheim respiratory therapies. RESPIMAT is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication. 

The RESPIMAT inhaler delivers medication independent of inspiratory effort. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

About SPIRIVA RESPIMAT in COPD
This FDA approval for asthma is the second indication for SPIRIVA RESPIMAT, which is already approved for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. SPIRIVA RESPIMAT is not indicated for the relief of acute bronchospasm.

Click here for full Prescribing Information, including Instructions for Use.

INDICATIONS
SPIRIVA RESPIMAT, 2.5 µg, is a prescription medicine used once daily (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations).

SPIRIVA RESPIMAT, 1.25 µg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 12 years and older.

SPIRIVA RESPIMAT is not a treatment for sudden symptoms of asthma or COPD.

IMPORTANT SAFETY INFORMATION

Do not use SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images, along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

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

SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection.

The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, sinus infection, bronchitis, and headache.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA RESPIMAT can increase side effects.

About Asthma
More than 22 million people in the U.S. have asthma. Asthma is a chronic disease and in the U.S., many patients taking currently available asthma treatments continue to experience symptoms. In a web-based survey of 1,812 asthma patients, 55 percent of patients taking asthma treatment still remained uncontrolled.

When a person with asthma comes into contact with an asthma trigger (e.g., infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

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.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.