FDA approves Stiolto Respimat Inhalation Spray as once-daily maintenance treatment of COPD

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s 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.

COPD is predicted to become the 3rd leading cause of death by 2030

COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease, affecting 210 million people worldwide. It is a growing world health priority and is predicted to become the 3rd leading cause of death by 2030. Patients are typically diagnosed when lung function is already significantly impaired. COPD symptoms can negatively impact a patient’s ability to breathe especially when performing daily activities.

“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, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.

Stiolto Respimat demonstrated statistically significant improvements in lung function over tiotropium and olodaterol alone

 “Stiolto Respimat produced greater lung function improvements in terms of FEV 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, 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.”

“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.”

The approval is based on data from the pivotal Phase III TONADO trials, which evaluated more than 5,000 COPD patients and showed Stiolto Respimat provides statistically significant improvements in lung function over tiotropium and olodaterol alone.