BOEHRINGER INGELHEIM RECEIVES FIRST MARKETING AUTHORIZATION FOR SPIRIVA® (TIOTROPIUM)
Boehringer Ingelheim announced today that it has received an approval from the Medicinal Evaluation Board in Den Haag, Netherlands for its COPD drug Spiriva® (tiotropium). Spiriva’s approved indication is for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease - COPD (including chronic bronchitis and emphysema). Discovered and developed by Boehringer Ingelheim, Spiriva® is the first once-daily inhaled therapy for COPD.
Official approval for Spiriva® is also expected in the near future from the Medicines Assessment Advisory Committee (MAAC), in New Zealand.
Boehringer Ingelheim expects the initiation of the European Mutual Recognition Procedure in early 2002. This means that Spiriva® could become available as early as mid-2002 in the initial countries. A new drug application for Spiriva® is expected to be filed with the U.S. Food and Drug Administration in the near future.
Tiotropium is a novel compound that works through prolonged M3-receptor antagonism. It has been shown to be effective in treating patients with COPD. Data from clinical trials presented recently at scientific meetings also show tiotropium to be superior to ipratropium bromide as well as to the long-acting beta agonist salmeterol in several key measurements.
While less well known than asthma, COPD is more prevalent. According to the World Health Organization, about 600 million people suffer from COPD, though many are undiagnosed. COPD is the world’s fourth-leading cause of death with approximately three million people dying each year from the smoking-related respiratory illness.
Shortness of breath, known as dyspnea, represents the most disabling respiratory symptom for patients with COPD. It is a slowly progressive airway disease that causes significant deterioration of lung function and consequently, disability and death. Smoking is the leading cause of COPD, but exposure to pollution and genetic predisposition are other known risk factors.
Earlier this year, Boehringer Ingelheim and Pfizer Inc announced that they have entered into a long-term worldwide agreement to co-promote Spiriva®.
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