FDA Expands Label, Indication for COPD Treatment Stiolto Respimat

OCTOBER 11, 2018
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has approved a broader indication and new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray.

The revised indication is for the treatment of patients with COPD, including chronic bronchitis and emphysema. Stiolto Respimat was previously approved in 2015 with an indication to treat airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The new labeling includes data showing that the tiotropium component in Stiolto Respimat reduces COPD exacerbations.

"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."

The label update will add data from a clinical trial of Spiriva Respimat (tiotropium bromide) Inhalation Spray as well as data from DYNAGITO, a 52-week study comparing Stiolto Respimat to Spiriva Respimat in the reduction of COPD exacerbations.

The double-blind DYNAGITO trial included 7880 patients with COPD and a history of exacerbations. Participants were randomized to receive either tiotropium–olodaterol 5 μg–5 μg (Stiolto Respimat) or tiotropium 5 μg (Spiriva Respimat) once daily.

The study found that the rate of moderate and severe COPD exacerbations was lower with Stiolto Respimat (rate ratio [RR] 0.93, 99% CI .85–1.02; P = .0498) but did not meet the target .01 significance level.

“Combining tiotropium and olodaterol did not reduce exacerbation rate as much as expected compared with tiotropium alone,” wrote investigators Peter M. A. Calverley, DSc, Antonio R. Anzueto, MD, and Kerstine Carter, MSc, et al.

The Stiolto Respimat Prescribing Information includes a boxed warning about the increased risk of death in patients with asthma who take long-acting beta2-adrenergic agonists (LABA) such as olodaterol. As olodaterol is one of the active ingredients in Stiolto Respimat, the spray is not indicated for the treatment of asthma.

The Prescribing Information additionally states that Stiolto Respimat is not to be initiated in acutely deteriorating COPD patients, is not for acute relief, and can cause life-threatening paradoxical bronchospasm, and can worsen narrow-angle glaucoma and urinary retention. The most common adverse reactions to Stiolto Respimat, which include nasopharyngitis, cough, and back pain.

"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.

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