Boehringer Ingelheim receives two FDA approvals

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• Striverdi® (olodaterol) Respimat® approved for the maintenance treatment of patients with COPD
• Jardiance® (empagliflozin) approved to reduce blood sugar levels in adults with type 2 diabetes

For Non-US/Non-UK media only

Ingelheim, Germany, August 4, 2014 – Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved two different products at the end of last week.

Striverdi® (olodaterol) Respimat® was approved in the US as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.Olodaterol is now approved in 40 countries worldwide. It is a highly selective long-acting ß2-agonist (LABA) that helps COPD patients breathe more easily within five minutes after the first inhaled dose and provides sustained improvement in lung function over 24 hours.1 Olodaterol has been specifically designed by Boehringer Ingelheim as a combination partner to Spiriva® (tiotropium), the most prescribed COPD maintenance therapy worldwide. A fixed-dose combination of both drugs in the Respimat® Soft MistTM Inhaler, the platform device of the respiratory portfolio, has recently been submitted for regulatory approval in the US and in the EU.

Jardiance® (empagliflozin) tablets were approved as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). Empagliflozin is part of the Boehringer Ingelheim – Eli Lilly and Company Diabetes Alliance. It is now the third product after Tradjenta® and Jentadueto® from this Alliance to be approved in the US.

Prof Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim

Prof Klaus Dugi

"There is currently a high unmet medical need both in COPD as well as in Type 2 Diabetes. Achieving two approvals in close proximity is a rare occasion for a pharmaceutical company and we are very much looking forward to bringing these additional therapeutic options to patients," said Prof Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "In the field of Diabetes, together with our partner Eli Lilly and Company, as well as in COPD, we are continuously expanding our product portfolio to provide more treatment options to patients"

For more information on the approvals of both Striverdi® Respimat® and Jardiance® see the respective US press releases Olodaterol and Empagliflozin. For additional information see Boehringer Ingelheim’s Corporate News Centre www.newshome.com.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

Reference
1Ferguson GT et al. Efficacy and safety of Olodaterol once daily delivered via Respimat® in patients with COPD 2-4 GOLD: results from two replicate 48-week studies. Int J COPD 2014; 9: 629-645

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