The U.S. Food and Drug Administration (FDA) recently approved a Supplemental New Drug Application (sNDA) for Boehringer Ingelheim Pharmaceuticals Inc.‘s Stiolto Respimat, adding data to the product’s labeling to reflect its demonstrated capacity to improve health-related quality of life in people with chronic obstructive pulmonary disease (COPD).
Data came from Phase 3 clinical trials, OTEMTO 1&2 (NCT01964352/NCT02006732), revealing a significant improvement in health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ), a self-reporting tool that evaluates activities, symptoms, and the disease impact on patients’ 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,” Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “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.”
Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray was approved by the FDA in May 2015 as a once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Tiotropium is an anticholinergic, and olodaterol is a long-acting beta2-adrenergic agonist.
Stiolto is administered via Respimat, the platform inhaler for the Boehringer Ingelheim respiratory therapies, including approved and investigational therapies. Respimat works by actively delivers a slow-moving mist to help patients breathe in the medication.
The label expansion was also based on data from the Phase 3 TONADO 1&2 (NCT01431274/NCT01431287) trials, which together with OTEMTO 1&2 evaluated Stiolto Respimat in more than 15,000 people worldwide with varying severities of COPD.
“I see first-hand how symptoms that COPD patients experience negatively impact their daily lives,” said Richard Casaburi, MD, PhD, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “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.”
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