BI’s Stiolto Respimat Wins FDA Nod

June 1, 2015

German drugmaker Boehringer Ingelheim has won FDA approval for Stiolto Respimat, the fourth Respimat inhaled drug that the FDA has allowed the company to market for chronic obstructive pulmonary disease.

Stiolto (tiotropium bromide and olodaterol) is meant to be used once a day with the company’s Respimat inhaler as a long-term maintenance treatment for airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It improves lung function in just five minutes and reduces patients’ dependence on rescue inhalers, BI says.

In clinical trials of more than 5,000 patients with differing severities of COPD, Stiolto Respimat was able to provide greater improvements in lung function than Spiriva Respimat (tiotropium bromide) or Striverdi Respimat (olodaterol) alone.  

Spiriva Respimat hit the U.S. market January, following FDA approval in September. Striverdi Respimat was approved a month earlier, while the older Combivent Respimat (ipratropium bromide & albuterol) garnered approval in 2011.

Spiriva and Combivent made BI’s top four highest-grossing Respimat-paired drugs in 2014, with Spiriva bringing in about $3.5 billion and Combivent $615 million. — Lena Freund