Stiolto Respimat for COPD Granted FDA's Supplemental NDA Approval

The FDA has approved a supplemental New Drug Application (sNDA) for Boehringer Ingelheim’s Stiolto Respimat, which, according to the company, adds data to the product’s label demonstrating improvements in health and quality of life for those suffering from chronic obstructive pulmonary disease (COPD).

“I see firsthand how symptoms that COPD patients experience negatively impact their daily lives,” said Prof. Richard Casaburi, M.D., Ph.D., associate chief of the Division of Respiratory and Critical Care Physiology and Medicine at Harbor-UCLA Medical Center, in a press release. “For people living with COPD, a treatment that helps improve their lung function and symptoms can positively impact their health-related quality of life and their everyday activity level.”

This label expansion is based on data from the TOviTO clinical trial program on Stiolto Respimat, which included more than 15,000 people with varying severities of COPD worldwide, including two 12-week placebo-controlled OTEMTO Phase 3 trials:

“Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)” (NCT01964352);
“Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)” (NCT02006732).

And two 52-week active-controlled TONADO trials:

All studies suggested a clinically meaningful improvement in quality of life associated with health, as determined by the St. George’s Respiratory Questionnaire (SGRQ) – a disease-oriented patient report that assesses symptoms, activity, and impact of the condition in the patient’s daily life.

Results from the OTEMTO 1 and 2 trials were recently published in the journal Respiratory Medicine under the title “Tiotropium + olodaterol shows clinically meaningful improvements in quality of life.”

“The health-related quality of life data builds upon the already existing clinical evidence establishing Stiolto Respimat as a proven treatment option for people living with COPD,” said Sabine Luik, M.D., Boehringer Ingelheim’s Medicine and Regulatory Affairs’ senior vice president. “This sNDA approval adds to the rich heritage of Boehringer Ingelheim as a respiratory industry leader. It is also the latest evidence of our over 40-year commitment to the COPD community.”

The Respimat Inhaler is the company’s platform inhaler for respiratory therapies. Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray is a combination of anticholinergic tiotropium and a long-acting beta2-adrenergic agonistic called olodaterol, which was approved for the long-term, once-daily maintenance treatment of airflow obstruction in COPD patients, including chronic bronchitis and emphysema patients, in May 2015.

For important indications and safety information concerning Stiolto Respimat, please read Boehringer Ingelheim’s indications of use document.

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