FDA Approves Asthma Indication For COPD Drug.

Food and Drug Administration has approved “the long-acting muscarinic antagonist tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for long-term maintenance treatment of asthma in people aged 12 years and older.” The drug has already been approved for treating chronic obstructive pulmonary disease (COPD).

• U.S. FDA latest regulatory authority to approve tiotropium in asthma 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, putting them at increased risk of potentially life-threatening asthma exacerbations. 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 exacerbation

The Phase III study results also showed that the safety of SPIRIVA® Respimat® is balanced as compared to placebo.