FDA Approves Boehringer Ingelheim’s Stiolto Respimat for Once-daily Maintenance Treatment of Airflow Obstruction in Patients with Chronic Obstructive Pulmonary Disease

Industry News

The US Food and Drug Administration announced that it has approved Stiolto Respimat for the once-daily maintenance treatment of airflow obstruction in patients with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and/or emphysema.  Stiolto Respimat is a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist developed by Boehringer Ingelheim, a global pharmaceutical company headquartered in Ingelheim, Germany.  COPD is a chronic obstructive lung disease characterized by poor airflow worsening over time.  The main symptoms include shortness of breath and cough.  Smoking is the most common cause of COPD.  Currently, there is no cure for COPD.  A phase III clinical trial sponsored by Boehringer Ingelheim to investigate the efficacy and safety of Stiolto Respimat in COPD patients showed greater lung function improvement with this new combination in comparison to tiotropium and olodaterol alone across all stages of the disease.

 

References:

  1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf
  2. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/5-20-15-new-data-analyses-investigational-tiotropium-olodaterol-respimat-showed-greater-lung-function-improvement-tiotropium-olodaterol.html
  3. https://clinicaltrials.gov/ct2/show/NCT01431274?term=tiotropium+AND+olodaterol&rank=4http://clinicaltrials.gov/ct2/show/NCT01431274?term=tiotropium+AND+olodaterol&rank=4

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