FDA approves Spiriva Respimat (tiotropium bromide) to treat asthma- Boehringer

Boehringer Ingelheim has announced that the 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 control. Significantly reduces the risk of patients having a severe asthma exacerbation by a fifth (21%)-reduces the number of patients who experienced a severe asthma exacerbations. 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 countries, including in the EU‡ and Japan.