FDA
15th August 2014

FDA Panel Supports Approval for Tiotropium Bromide Inhalation Spray

Yesterday, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) committee discussed the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim (BI) Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations.

FDA Panel Supports Approval for Tiotropium Bromide Inhalation Spray

August 14, 2014 8:00 a.m. to 4:00 p.m.: Pulmonary-Allergy Drugs Advisory Committee Meeting

Yesterday, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) committee discussed the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim (BI) Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion included efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

PADAC voted 10 yes and 3 no, that existing data supports approval of tiotropium bromide inhalation spray. This decision followed a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium (in the Respimat device). One of these trials, TIOSPIR (the largest clinical trial conducted in patients with COPD) collected data from more than 17,000 COPD patients from 50 countries.

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 SpirivaHandiHaler (tiotropium bromide inhalation powder). If approved, tiotropium Respimat would provide health providers and their patients with a choice between a mist and dry powder inhaler for the delivery of tiotropium. 

Stephen Rennard, Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center stated, “As a practicing physician, it’s essential to have multiple treatment choices available when assessing how to help people affected by this devastating disease.”

The FDA is not bound by PADAC’s decision, but takes it into consideration when reviewing the application. If approved, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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