FDA Approves Stiolto Respimat sNDA to Add Data on COPD Exacerbation Reduction

Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in Spiriva Respimat (tiotropium bromide) Inhalation Spray. Stiolto Respimat is a combination medicine that includes tiotropium.

The FDA also revised the indication for Stiolto Respimat, which is now approved for the treatment of patients with COPD, including chronic bronchitis and emphysema. Previously, the Stiolto Respimat indication was for the treatment of airflow limitation in patients with COPD, including chronic bronchitis and emphysema. The revised language broadens the indication and illustrates that Stiolto Respimat does more than simply improve airflow.

"Also known as flare-ups, exacerbations are a serious complication from COPD that can further damage the lungs and make management of the disease more difficult," said Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas, Health, San Antonio. "When I'm treating my patients with COPD, it's important to make sure I am taking steps to reduce their risk for an exacerbation, which could result in hospitalization or other serious complications."

A COPD exacerbation is a sudden worsening of symptoms, such as increased breathlessness, cough, mucus production and extreme fatigue. Exacerbations can have a significant negative impact on people with COPD because they can cause permanent lung damage and possibly lead to lengthy hospitalizations or even death. In addition to the detrimental effects on peoples' health, COPD exacerbations have a significant burden on the healthcare system as a whole.

"This approval adds comprehensive data to the label of Stiolto Respimat, giving healthcare providers and those living with COPD important information about how the medicine can help reduce the risk of a COPD exacerbation," said Thomas Seck, MD, Senior Vice President of Medicine and Regulatory Affairs at Boehringer Ingelheim. "Boehringer Ingelheim is dedicated to advancing our clinical research program to help people living with chronic, debilitating respiratory diseases, such as COPD, better manage their conditions."

The Stiolto Respimat label will be updated to include clinical trial data of Spiriva Respimat that shows a decrease in exacerbations, as well as data from the Dynagito trial, a 52-week study involving more than 7,800 people across a broad range of people living with COPD, comparing Stiolto Respimat to Spiriva Respimat in the reduction of COPD exacerbations.

People with asthma, who take long-acting beta2-agonist medicines such as olodaterol, one of the medicines in Stiolto Respimat, have an increased risk of death from asthma. Stiolto Respimat should not be used to treat asthma and should not be used for treating sudden symptoms of COPD. People should not use Stiolto Respimat if they are allergic to tiotropium, ipratropium, olodaterol, or any ingredient in Stiolto Respimat. As with other inhaled medicines, Stiolto Respimat can cause serious side effects, including sudden shortness of breath that may be life threatening. The most common side effects are runny nose, cough and back pain.

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