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FDA Approves Spiriva Respimat for Asthma

Boehringer Ingelheim inhaler gains additional indication

The FDA has approved tiotropium (Spiriva Respimat, Boehringer Ingelheim) 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 (GINA) 2015 Global Strategy for Asthma Management and Prevention.

Nearly 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 combined inhaled corticosteroid/long-acting beta agonist (ICS/LABA) maintenance therapy improves asthma symptoms. The study found that Spiriva Respimat patients were 68% more likely to improve asthma control. Additionally, the number of patients having a severe asthma exacerbation was reduced by 21%.

Spiriva Respimat was already approved in the United States for the maintenance treatment of chronic obstructive pulmonary disease (COPD) at a once-daily dose of 5 mcg (delivered in two puffs of 2.5 mcg each).

For asthma maintenance, the FDA approved a once-daily dose of 2.5 mcg (delivered in two puffs of 1.25 mcg each).

Spiriva Respimat is not a treatment for the sudden symptoms of asthma or COPD.

Sources: Boehringer Ingelheim; September 16, 2015; Medscape; September 16, 2015.

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