FDA Approves Stiolto® Respimat® Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction

Ridgefield, Conn., October 11, 2018 – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in Spiriva Respimat (tiotropium bromide) Inhalation Spray. Stiolto Respimat is a combination medicine that includes tiotropium.

The FDA also revised the indication for Stiolto Respimat, which is now approved for the treatment of patients with COPD, including chronic bronchitis and emphysema. Previously, the Stiolto Respimat indication was for the treatment of airflow limitation in patients with COPD, including chronic bronchitis and emphysema. The revised language broadens the indication and illustrates that Stiolto Respimat does more than simply improve airflow.

“Also known as flare-ups, exacerbations are a serious complication from COPD that can further damage the lungs and make management of the disease more difficult,” said Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas, Health, San Antonio. “When I’m treating my patients with COPD, it’s important to make sure I am taking steps to reduce their risk for an exacerbation, which could result in hospitalization or other serious complications.”

A COPD exacerbation is a sudden worsening of symptoms, such as increased breathlessness, cough, mucus production and extreme fatigue. Exacerbations can have a significant negative impact on people with COPD because they can cause permanent lung damage and possibly lead to lengthy hospitalizations or even death. In addition to the detrimental effects on peoples’ health, COPD exacerbations have a significant burden on the healthcare system as a whole.

“This approval adds comprehensive data to the label of Stiolto Respimat, giving healthcare providers and those living with COPD important information about how the medicine can help reduce the risk of a COPD exacerbation,” said Thomas Seck, MD, Senior Vice President of Medicine and Regulatory Affairs at Boehringer Ingelheim. “Boehringer Ingelheim is dedicated to advancing our clinical research program to help people living with chronic, debilitating respiratory diseases, such as COPD, better manage their conditions.”

The Stiolto Respimat label will be updated to include clinical trial data of Spiriva Respimat that shows a decrease in exacerbations, as well as data from the DYNAGITO® trial, a 52-week study involving more than 7,800 people across a broad range of people living with COPD, comparing Stiolto Respimat to Spiriva Respimat in the reduction of COPD exacerbations.

People with asthma, who take long-acting beta2-agonist medicines such as olodaterol, one of the medicines in Stiolto Respimat, have an increased risk of death from asthma. Stiolto Respimat should not be used to treat asthma and should not be used for treating sudden symptoms of COPD. People should not use Stiolto Respimat if they are allergic to tiotropium, ipratropium, olodaterol, or any ingredient in Stiolto Respimat. As with other inhaled medicines, Stiolto Respimat can cause serious side effects, including sudden shortness of breath that may be life threatening. The most common side effects are runny nose, cough and back pain.

Please see complete Important Safety Information below.

About the Respimat Inhaler
The Respimat inhaler was designed to get the medicine deep into patients’ lungs and delivers medicine as a slow-moving mist that helps patients inhale it. Unlike certain dry powder inhalers that require a deep breath to optimally inhale the medicine, the Respimat inhaler operates 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).

Boehringer Ingelheim’s Respimat family of products includes five FDA-approved medicines for COPD and asthma. The Respimat inhaler is the first and only inhaler acknowledged by the Arthritis Foundation as easy-to-use for people with arthritis.

Important Safety Information for STIOLTO RESPIMAT
People with asthma who take long-acting beta2-agonist (LABA) medicines alone, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins, and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.

STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar, or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, 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.

STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

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.

Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.

Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Information, including boxed WARNING.

Indication for STIOLTO RESPIMAT
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

Important Safety Information for SPIRIVA RESPIMAT
Do not use SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray 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.

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.

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.

Read the step-by-step patient Instructions for Use for SPIRIVA RESPIMAT before you use your inhaler.

Please see accompanying Full Prescribing Information

Indication for SPIRIVA RESPIMAT
SPIRIVA RESPIMAT, 2.5 mcg, is a long-term, once-daily, prescription maintenance medicine used 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 is not a treatment for sudden symptoms of COPD.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives.

In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.

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

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