BOEHRINGER-INGELHEIM

Boehringer Ingelheim today announced that SPIRIVA^® RESPIMAT^® is now available for the treatment of asthma by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of 2.5 µg for the long-term maintenance treatment of asthma in people ages 12 and older.^{6 *}

“Despite taking other daily maintenance treatments, many people with asthma continue to experience symptoms, including coughing, wheezing, shortness of breath,” said Michael B. Foggs, MD, Chief of Allergy & Immunology, Advocate Medical Group, Advocate Health Care Chicago, IL.^7,8 “For these patients, adding SPIRIVA^® RESPIMAT^® to maintenance controller therapy may help open airways to improve breathing and reduce the likelihood of asthma flare-ups or exacerbations^± .”⁶

People with asthma who continue to experience symptoms during the course of a week have a six times greater chance of having an asthma flare-up in the following few weeks than those with minimal to no daytime symptoms.⁵ These persistent symptoms can have a negative impact on the ability to perform daily activities for people living with asthma.

Unlike other asthma daily maintenance treatments, SPIRIVA^® RESPIMAT^® is from a new class of medications in asthma known as long-acting anticholinergics (LAMAs), the first new class of inhaled medicine approved in over 10 years for asthma.

SPIRIVA^® RESPIMAT^® in asthma is delivered by RESPIMAT^® , the inhaler which actively^{^} delivers a unique mist,⁹ meaning the patient just needs to breathe in naturally¹⁰ for the medication to go deep into the lungs.^11,12,13

“SPIRIVA^® RESPIMAT^® is a new treatment option for asthma patients who remain symptomatic despite their maintenance treatment,” said Dr. William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim. “SPIRIVA^® RESPIMAT^® significantly improves lung function and reduces the risk of exacerbations in patients who remain symptomatic despite their maintenance treatment and is included in the 2015 GINA Global Strategy for Asthma Management and Prevention.”

The FDA approved SPIRIVA^® RESPIMAT^® for the treatment of asthma 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).⁶

For more information on the U.S. FDA approval of SPIRIVA^® RESPIMAT^® in asthma, see the respective U.S. press release here.

For more information on SPIRIVA^® RESPIMAT^® and asthma, please visit Boehringer Ingelheim News Centre .

For references and notes to editors please visit http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/04_Februar_2016_asthma.html

* SPIRIVA^® RESPIMAT^® is not a treatment for sudden asthma symptoms

± An asthma exacerbation is defined as a progressive increase in asthma symptoms (shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms) or a decrease in a patient’s best morning peak expiratory flow (PEF) that requires treatment with systemic steroids for at least three days.

^ RESPIMAT^® delivers a metered dose of medication in a mist at the push of a button requiring just a slow deep breath from a patient

View source version on businesswire.com: http://www.businesswire.com/news/home/20160204005318/en/

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Boehringer Ingelheim
Corporate Communications
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Katharina Opitz
55216 Ingelheim/Germany
Phone: +49 6132 – 77 2012
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com