US FDA approves Spiriva HandiHaler

Published: 18-Dec-2009
Regulatory

Boehringer Ingelheim and Pfizer say the US Food and Drug Administration has approved the Spiriva HandiHaler for the reduction of exacerbations (worsening symptoms) in patients with chronic obstructive pulmonary disease (COPD). The device is already approved as a once-daily treatment for breathing problems associated with COPD, which includes chronic bronchitis, emphysema, or both.


Boehringer Ingelheim and Pfizer say the US Food and Drug Administration has approved the Spiriva HandiHaler for the reduction of exacerbations (worsening symptoms) in patients with chronic obstructive pulmonary disease (COPD). The device is already approved as a once-daily treatment for breathing problems associated with COPD, which includes chronic bronchitis, emphysema, or both.

The new indication is supported by data from two clinical trials: the UPLIFT (Understanding the Potential Long-term impacts on Function with Tiotropium) study and a six-month trial involving around 8,000 people with COPD.

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