The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray 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 by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.
The Advisory Committee voted that existing data supports approval after a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium in the RESPIMAT inhaler. One of these trials, TIOSPIR, the largest clinical trial conducted to date in patients with COPD, collected data from more than 17,000 COPD patients from 50 countries.
"As a practicing physician, it's essential to have multiple treatment choices available when assessing how to help people affected by this devastating disease," said Stephen Rennard, M.D., professor, internal medicine, division of pulmonary, critical care, sleep and allergy, University of Nebraska Medical Center.
The Advisory Committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval.
"We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium RESPIMAT in the U.S.," said Sabine Luik, M.D., senior vice president, medicine and regulatory affairs, Boehringer Ingelheim Pharmaceuticals. "At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium RESPIMAT would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option."
RESPIMAT is a multi-dose, propellant-free inhaler that uses mechanical energy to generate a slow-moving mist to deliver tiotropium, the same active ingredient as Spiriva HandiHaler (tiotropium bromide inhalation powder). If approved, tiotropium RESPIMAT would provide physicians and their patients with a choice between a mist and dry powder inhaler for tiotropium.
The availability and continued use of SPIRIVA HandiHaler is not affected by the Advisory Committee vote or subsequent FDA decision. SPIRIVA HandiHaler has an established efficacy and safety profile based on 29 placebo controlled clinical trials in over 12,000 patients.