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Biopharmaceuticals FDA

 News Release - February 16, 2017

FDA Expands Approval of SPIRIVA(R) RESPIMAT(R) (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children

RIDGEFIELD, Conn., Feb. 16, 2017 -- (Healthcare Sales & Marketing Network) -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric exclusivity to SPIRIVA RESPIMAT in light of the clinical trials conducted by Boehringer Ingelheim.

SPIRIVA RESPIMAT is steroid-free and works differently from other treatment options to open airways to help people breathe better. In its comprehensive clinical trial program, SPIRIVA RESPIMAT demonstrated proven efficacy and safety for patients age 6 and older.

"It is important for healthcare providers to identify and treat patients who may be taking a controller medicine, but who continue to experience uncontrolled asthma symptoms that can make it difficult to breathe and may even cause an exacerbation," said Bradley E. Chipps, MD, Capital Allergy & Respiratory Disease Center, Sacramento, California. "As healthcare providers, we need options, like SPIRIVA RESPIMAT, to consider as an add-on treatment to improve asthma symptoms for the broad age range of patients who may need more control."

SPIRIVA RESPIMAT, which is delivered as 2 puffs once a day of 1.25 mcg per puff, is part of a class of medicines called long-acting muscarinic antagonist (LAMA) and is the only one of its kind approved for asthma. SPIRIVA RESPIMAT was approved in September 2015 for the long-term, once-daily, prescription maintenance treatment of asthma in people age 12 and older. In the treatment of asthma, the maximum benefits in breathing may take up to 4 to 8 weeks.

Asthma is a chronic respiratory disease that can cause airways to become narrower and irritated, making it difficult to breathe. It currently affects nearly 6.3 million American children. Asthma symptoms can be serious, and uncontrolled asthma could lead to emergency room visits, hospital stays and missed days of school.

"This FDA approval expands the indication of SPIRIVA RESPIMAT to a broad range of people, including children, adolescents and adults who may be experiencing uncontrolled asthma," said Sabine Luik MD, Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "For nearly a century, Boehringer Ingelheim has been focused on addressing serious unmet needs. This approval is further evidence of our ongoing commitment to improving the lives of the patients we serve."

This FDA approval is based on efficacy and safety data from the Phase II and Phase III UniTinA-asthmaŽ clinical development program, which included more than 150 sites globally with over 6,000 patients, including 804 children (aged 6-11 years).

About Asthma

More than 24 million people in the U.S. have asthma, including 6.3 million children under the age of 18. Asthma is a chronic disease and despite taking maintenance treatments, many children and adults continue to have uncontrolled asthma. According to the CDC, 50 percent of adults and over 38 percent of children with asthma in the U.S. remain symptomatic, despite maintenance treatment.

When a person with asthma comes into contact with an asthma trigger (e.g., infections, pollen, and 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.

About the RESPIMAT Inhaler

RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, was designed to get medicine deep into patients' lungs as a slow-moving mist. The slow moving mist of the RESPIMAT inhaler provides patients with enough time to breathe in the medication. The RESPIMAT inhaler operates independent of inspiratory effort, helping patients effectively breathe the medicine into their lungs while minimizing inhalation 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.

Important Safety Information

Do not use SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in this medicine.

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 machinery.

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 with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.

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.

Indication

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

Please see full Prescribing Information and Instructions for Use for SPIRIVA RESPIMAT.

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 145 affiliates and about 50,000 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 their 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 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

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


Source: Boehringer Ingelheim

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