Tiotropium Bromide and Olodaterol Labeling Updated With Revised Indication

FDA new indication
The FDA has approved updated labeling for Stiolto Respimat to include COPD exacerbation data and a revised indication.

The Food and Drug Administration (FDA) has approved updated labeling for Stiolto Respimat (tiotropium bromide and olodaterol; Boehringer Ingelheim) to include chronic obstructive pulmonary disease (COPD) exacerbation data and a revised indication.

The new data includes a study evaluating Spiriva Respimat (tiotropium 5mcg inhalation spray; Boehringer Ingelheim) in patients with COPD with a history of exacerbations. Results showed that the treatment, which shares the same active ingredient as Stiolto Respimat, significantly reduced exacerbations and delayed the time to first COPD exacerbation. 

In a trial comparing Stiolto Respimat to Spiriva Respimat in patients with COPD, Stiolto Respimat was not found to be superior to Spiriva Respimat for the primary endpoint, the annualized rate of moderate to severe COPD exacerbations, with a rate ratio of 0.93 (99% CI, 0.85-1.02, P=.0498).

“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.

In addition to the new exacerbation data, the indication for Stiolto Respimat has been revised. Stiolto Respimat is now indicated for long-term, once-daily maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema. Previously, the indication was for the treatment of airflow limitation in these patients.

Stiolto Respimat combines tiotropium bromide, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). It is administered via the Respimat Inhaler which delivers a slow-moving mist to help patients inhale the medication. Each actuation from the mouthpiece contains 3.124mcg tiotropium bromide monohydrate, equivalent to 2.5mcg tiotropium, and 2.736mcg olodaterol hydrochloride, equivalent to 2.5mcg olodaterol.

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For more information visit Boehringer-Ingelheim.com.

This article originally appeared on MPR