FDA Approves Boehringer Ingelheim’s Stiolto Respimat as Once-Daily Maintenance Treatment for COPD

Boehringer Ingelheim has announced that the FDA approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.

“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 help healthcare providers with their goal of improving lung function,” said Danny McBryan, vice president, Clinical Development & Medical Affairs, Respiratory, 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, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “As a clinician, I am pleased to have a new treatment option to offer my patients.”

Tiotropium is a long-acting anticholinergic and the active ingredient in Spiriva Respimat and Spiriva HandiHaler. Since its approval more than 10 years ago, Spiriva has extensive clinical experience with over 40 million patient-years and more than 200 clinical trials. Spiriva is the most prescribed COPD maintenance treatment worldwide.

Olodaterol, marketed as Striverdi Respimat, is a long-acting beta2-agonist that was specifically designed to complement the efficacy of Spiriva. Olodaterol has a fast onset of action that has a clinically meaningful improvement in airflow five minutes after the first dose.

“The approval of Stiolto Respimat in the US 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.”