FDA approves Stiolto Respimat for the treatment of COPD

According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation Spray, in August 2014.

New data analyses from Phase 3 studies showing improved lung function for patients using the combination product compared to the individual components were presented recently at ATS 2015.

Boehringer Ingelheim Pharmaceuticals VP, Clinical Development & Medical Affairs, Respiratory, Danny McBryan commented, “A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will improve lung function.”

The individual components of Stiolto Respimat are marketed as Spiriva Respimat (tiotropium bromide), approved by the FDA in September 2014, and Striverdi Respimat (olodaterol), approved in July 2014.

Read the Boehringer Ingelheim press release.