Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for its once-daily Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray.
The FDA granted the approval for Stiolto Respimat as a long-term and once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Marketed as Stiolto Respimat, olodaterol is a long-acting beta2-agonist that has been specifically designed to complement the efficacy of Spiriva, which is the most prescribed COPD maintenance treatment worldwide.
Stiolta is administered through Respimat, the propellant-free, platform inhaler for Boehringer Ingelheim's respiratory therapies, including approved and investigational therapies.
Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "The approval of Stiolto Respimat in the US marks an important milestone in our ongoing commitment to provide effective solutions for patients with COPD.
"Building on years of trusted experience with Spiriva, Stiolto Respimat provides even further benefits than Spiriva alone and will offer a valuable new treatment option for patients and physicians."
The approval was based on data from the pivotal Phase III Tonado I&II trials (NCT01431274/NCT01431287), which assessed more than 5,000 COPD patients.
The trials demonstrated that the drug provides statistically significant improvements in lung function over tiotropium and olodaterol alone.
Conducted as part of the TOviTO clinical trial programme that involved around 15,000 COPD patients across the globe, the trials demonstrated that Stiolto Respimat has a safety profile similar to tiotropium or olodaterol alone.
