FDA Approves New Label for Stiolto Respimat Showing Efficacy Against COPD Flare-ups

The U.S. Food and Drug Administration (FDA) approved a new label for Stiolto Respimat (a combination therapy of tiotropium bromide and olodaterol) based on data from clinical trials showing a significant reduction in the frequency of chronic obstructive pulmonary disease (COPD) exacerbations driven by tiotropium, the active ingredient of Spiriva Respimat, another inhalation spray.

Both Stiolto Respimat and Spiriva Respimat are marketed by Boehringer Ingelheim.

The FDA will change the current therapeutic indication for Stiolto Respimat, which had been to control COPD symptoms by treating limited airflow, to a broader indication announcing that the inhalation spray does more than simply improve patients’ lung airflow, as it can also reduce exacerbations.

COPD exacerbations are acute episodes in which patients experience a significant aggravation of symptoms, including increased breathlessness, cough, mucus production, and extreme fatigue. If not addressed, these episodes can cause permanent lung damage, and lead to patients’ hospitalization and, in some cases, death.

“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,” Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas, Health, San Antonio, said in a press release.

“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,” Anzueto said.

The label of Stiolto Respimat will be updated to include data from clinical trials showing a reduction in COPD exacerbations. In particular, data from the DYNAGITO trial (NCT02296138) will be included. DYNAGITO is a 52-week Phase 3 study involving more than 7,800 COPD patients from 51 countries who had at least one moderate or severe exacerbation requiring antibiotic and/or glucocorticoid treatment or hospitalization within the previous year.

The primary goal of the study was to compare the efficacy of Stiolto Respimat in reducing the prevalence of moderate and severe COPD exacerbations to that of Spiriva Respimat. Trial data revealed that Stiolto Respimat decreased the frequency of moderate to severe exacerbations by 7 percent in comparison with Spiriva Respimat.

“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,” Seck said.