The US FDA has approved a supplemental New Drug Application (sNDA) for Boehringer Ingelheim Pharmaceuticals’ Stiolto Respimat that adds data showing improvement in health-related quality of life among people with COPD to the product labelling.
These data, which are from the OTEMTO 1 & 2 clinical studies, show a clinically meaningful improvement in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ), the company said.
“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.”
“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, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “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 is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms, according to the company. Stiolto Respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. As with other inhaled medicines, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening. The most common adverse reactions were nasopharyngitis, cough and back pain.