Boehringer Ingelheim announced that the FDA has approved once-daily Stiolto™ Respimat^® (tiotropium bromide and olodaterol) Inhalation Spray. The drug was approved for long-term continuation therapy of the obstruction of the airflow in chronic obstructive pulmonary disease (COPD) patients. Patients with asthma or acute deterioration of COPD are not eligible for Stiolto Respimat.

COPD affects about 210 million people worldwide and includes emphysema and chronic bronchitis. COPD is a treatable condition and is a leading world health priority, with estimates indicating that the condition will be the third cause of mortality by the year of 2030.

“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,” said Danny McBryan, MD, vice president of Clinical Development & Medical Affairs, Respiratory, at Boehringer Ingelheim Pharmaceuticals, Inc.

“Stiolto Respimat produced greater lung function improvements in terms of FEV₁ compared to tiotropium and olodaterol alone in patients with COPD across a range of severities (GOLD 2 to 4),” said Richard Casaburi, MD, PhD, professor and associate chief in the Division of Respiratory and Critical Care Physiology and Medicine at Harbor-UCLA Medical Center. “As a clinician, I am pleased to have a new treatment option to offer my patients.”

The operational ingredient of Spiriva Respimat and Spiriva HandiHaler is called Tiotropium, which is an anticholinergic, approved a decade ago. Spiriva has been evaluated in about 40 million patient-years and in about 200 studies and is the most prescribed maintenance treatment for COPD.

Olodaterol, known as Striverdi Respimat, is a beta2-agonist designed to work as a complement to Spiriva. The drug has a rapid mechanism of action and has been found to improve the airflow five minutes following first dosing.

“The approval of Stiolto Respimat in the U.S. marks an important milestone in our ongoing commitment to provide effective solutions for patients with COPD,” said Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “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. We look forward to the decision from the European regulatory authorities soon.”

The FDA approval was based on the results from the Phase III TONADO 1&2 clinical trials, which examined about 5,000 patients with COPD and found that Stiolto Respimat improves lung function in comparison with tiotropium and olodaterol alone.  Stiolto Respimat was also found to have a safety profile identical to olodaterol or tiotropium alone.