Boehringer Ingelheim and Pfizer have received FDA approval for Spiriva HandiHaler (tiotropium bromide inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Spiriva HandiHaler is already FDA-approved as a once-daily maintenance 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: UPLIFT (Understanding the Potential Long-term Impacts on Function with Tiotropium) study, and a six-month study conducted in the Veterans Affairs setting, which together involved nearly 8,000 people with COPD. While the UPLIFT trial did not meet its primary endpoint (slowing the rate of decline in lung function versus placebo), it provided relevant and important clinical information regarding the effect of Spiriva HandiHaler on COPD exacerbations.
Christopher Corsico, vice president of drug regulatory affairs at Boehringer Ingelheim, said: “With today’s approval, Spiriva HandiHaler is now the first steroid-free maintenance treatment that has been shown to reduce COPD exacerbations. We also are pleased that the product label will now include data from the landmark UPLIFT trial, which provides important information for physicians to consider when making treatment decisions.”
Along with the new indication, the Spiriva HandiHaler product label now includes clinical trial data from the UPLIFT study. In this trial, COPD patients in both treatment groups were allowed to use all of their respiratory medications with the exception of inhaled anticholinergics, in order to simulate a real-world environment.
The clinical data demonstrated that Spiriva HandiHaler sustained improved lung function over four years when compared with placebo and reduced COPD exacerbations, even with the use of these medications. Additionally, the inclusion of the safety data reaffirmed the established safety profile of Spiriva HandiHaler.
The safety profile of Spiriva HandiHaler has been well-established in clinical studies involving more than 17,000 COPD patients, 11,000 of whom were treated with Spiriva HandiHaler, and in post-marketing experience involving more than 16 million patient-years of exposure, since its European approval in 2002. Spiriva HandiHaler was approved in the US in 2004.