In a 10-to-3 vote by the Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee (FDA PADAC), Boehringer Ingelheim Pharmaceuticals, Inc.’s investigational nasal spray tiotropium bromide has been recommended for approval to maintain treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD). The recommendation came as a result of data generated in clinical studies that shows a benefit of tiotropium bromide on COPD patient survival and on lung function in conjunction with beta agonists.
“We are pleased with the endorsement from PADAC members and recommendation of approval for tiotropium RESPIMAT in the US,” said Sabine Luik, MD, senior vice president of Medicine & Regulatory Affairs at Boehringer Ingelheim, in a news release from PR Newswire. If approved, tiotropium bromide will be marketed under the name Spiriva® Respimat®.
The PADAC cited eight efficacy clinical trials involving 8,700 patients treated with tiotropium in the Respimat inhaler when making a decision. In an international trial, 17,000 COPD patients from 50 countries were treated–the largest trial evaluating tiotropium bromide.
Spiriva Respimat is not an entirely new concept; it uses the same active ingredient in Spiriva® HandiHaler® (tiotropium bromide inhalation powder) but delivers the drug as a slow-moving mist through Respimat, a multi-dose, propellant free inhaler. “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, MD, Professor of Internal Medicine in the Division of Pulmonary, Critical Care, Sleep & Allergy at the University of Nebraska Medical Center.
The recommendation by the PADAC is non-binding. Ultimately, the FDA makes the final decision for approval. Whether or not Spiriva Respimat is approved has no effect on the availability and continued use of Spiriva HandiHaler, which has proven to be safe and efficacious in 29 trials involving over 12,000 patients.
“At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades,” sad Dr. Luik. “If approved, tiotropium Respimat would build upon our heritage in treating respiratory disease by equipping healthcare providers and their patients with an important new treatment option.”