Boehringer Ingelheim has filed for marketing approval with regulatory authorities in Europe, where Spiriva could be available as early as mid-2002.
A new drug application for Spiriva is anticipated to be filed with the US Food and Drug Administration later this year.
Spiriva, discovered and developed by Boehringer Ingelheim, would be the first once-a-day inhaled brochodilator treatment for COPD and represents a significant advance over other treatment options.
According to the World Health Organization, about 600 million people suffer from COPD, though many are undiagnosed. The disease claims three million lives annually. It is estimated that one in five smokers will develop COPD.
"We’re very pleased to be working with Pfizer in co-promoting Spiriva," said Prof. Rolf Krebs, chairman of the Board of Managing Directors at Boehringer Ingelheim. "Through this agreement, we gain a strong and experienced partner who will help increase awareness of the disease and of the significant patient benefits that this novel compound delivers."
"We fully expect Spiriva to be an important treatment option for condition that is debilitating to patients and costly to health care systems worldwide," said Pfizer chief executive officer Hank McKinnell.
COPD is a chronic respiratory disorder characterized by limited airflow accompanied by symptoms such as shortness of breath, cough, wheezing and increased sputum production.
As the disease progresses, patients become increasingly disabled, although at first they may attribute their symptoms to aging. Currently, there are no specific medications that are fully effective in treating COPD.
COPD is a major socioeconomic burden. It is the fourth leading cause of death in the United States, exceeded only by heart attacks, cancer and stroke. The WHO Annual World Health report estimates that 600 million people worldwide suffer from COPD and approximately three million of them die each year.
Data from clinical trials involving more than 3,000 patients worldwide have demonstrated that Spiriva is highly effective, proving sustained bronchodilation with significant symptomatic improvement in shortness of breath.
Data also indicate that Spiriva reduced exacerbations of COPD, resulting in fewer hospitalizations. Spiriva was shown to be well-tolerated.