U.S. FDA latest regulatory authority to approve SPIRIVA® (tiotropium) Respimat® in asthma1 following authorities in the EU, Japan and other countries
Recent GINA 2015 Global Strategy recommends tiotropium by soft mist inhaler as add-on asthma therapy
Ingelheim, Germany, 16. September, 2015 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA® Respimat® (tiotropium bromide) Inhalation Spray for use in the treatment of asthma. It is approved by the FDA for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older†. Following previous regulatory approvals, tiotropium by soft-mist inhaler has been included in the recently updated Global Initiative for Asthma report (GINA) 2015 Global Strategy for Asthma Management and Prevention*.Almost one in two patients with asthma still experience symptoms while receiving maintenance therapy,3,4,5 putting them at increased risk of potentially life-threatening asthma exacerbations.6 Pivotal, Phase III study results show that Spiriva® Respimat® as an add-on treatment to ICS/LABA maintenance therapy:
- • Significantly improves asthma symptoms
- • patients are 68% more likely to improve asthma control7
- • Significantly reduces the risk of patients having a severe asthma exacerbation by a fifth (21%)
reducing the number of patients who experienced a severe asthma exacerbation8
The Phase III study results also showed that the safety of SPIRIVA® Respimat® is balanced as compared to placebo.
Since 2014, SPIRIVA® Respimat® has been approved for use in asthma in over 50 countries1, including in the EU‡ and Japan§.
Dr William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim
“The U.S. FDA approval of SPIRIVA® Respimat® in asthma establishes a new class of inhaled asthma therapy and provides an efficacious, new option for patients. There is extensive clinical evidence demonstrating that SPIRIVA® Respimat® can improve outcomes for patients with asthma who remain symptomatic despite the use of ICS/LABA maintenance therapy. This is reflected by the inclusion of SPIRIVA® Respimat® in the latest update of the GINA global asthma management strategy,” said Dr William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim.