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FDA Advisors Back Tiotropium Respimat for Maintenance Treatment of COPD

Positive decision based on data from eight efficacy trials

The FDA’s Pulmonary–Allergy Drugs Advisory Committee (PADAC) has voted 10 to 3 that existing data support approval of an investigational tiotropium bromide inhalation spray (Boehringer Ingelheim) for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients.

If approved, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

The advisory committee voted that existing data support approval after a review of the results from eight clinical trials in which a total of 8,700 patients were treated with tiotropium in the Respimat device. One of these trials (TIOSPIR) collected data from more than 17,000 COPD patients in 50 countries.

The advisory committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval.

Respimat is a multidose, propellant-free inhaler that uses mechanical energy to generate a slow-moving mist to deliver tiotropium — the same active ingredient in the Spiriva HandiHaler (tiotropium bromide inhalation powder). If approved, tiotropium Respimat would provide physicians and their patients with a choice between a mist inhaler and a dry-powder inhaler for the delivery of tiotropium.

The availability and continued use of the Spiriva HandiHaler is not affected by the advisory committee’s vote or by the FDA’s subsequent decision.

Source: Boehringer Ingelheim; August 14, 2014.

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