According to Boehringer Ingelheim Pharmaceuticals, the FDA has approved a supplemental NDA for the Stiolto Respimat tiotropium/olodaterol SMI for a labeling change to add quality of life data obtained from the OTEMTO 1&2 studies. Stiolto Respimat, which was initially approved for the treatment of COPD by the FDA in May 2015, is approved as Spiolto Respimat in some European countries.
BI Pharmaceuticals Senior VP, Medicine & Regulatory Affairs Sabine Luik commented, “The health-related quality of life data builds upon the already existing clinical evidence establishing Stiolto Respimat as a proven treatment option for people living with COPD. This sNDA approval adds to the rich heritage of Boehringer Ingelheim as a respiratory industry leader. It is also the latest evidence of our over 40-year commitment to the COPD community.”
Read the Boehringer Ingelheim press release.
