Boehringer Ingelheim receives two FDA approvals

Posted: 4 August 2014 | | No comments yet

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.

“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