Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved a sNDA for Stiolto Respimat that adds data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (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), which is a disease-specific patient-reported instrument that evaluates symptoms, activities, and the impact of the disease on daily life.
“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.”
Long-acting beta2-adrenergic agonists, such as olodaterol, one of the active ingredients in Stiolto Respimat, increase the risk of asthma-related death. Stiolto Respimat is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. 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.
Stiolto Respimat (www.STIOLTO.com) was approved in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.
Favorable access to Stiolto Respimat continues to expand and it is widely covered with Commercial and Medicare insurance plans, including Optum, Humana, Aetna and CIGNA. Medicare coverage of Stiolto Respimat, in particular, has significantly exceeded expectations.
The label expansion is based on data from two sets of Phase III trials—OTEMTO 1&2 (NCT01964352/NCT02006732) and TONADO® 1&2 (NCT01431274/NCT01431287)—from the TOviTO clinical trial program for Stiolto Respimat, which includes more than 15,000 people with varying severities of COPD worldwide. OTEMTO® 1&2 were 12-week placebo-controlled trials, and TONADO 1&2 were 52-week active-controlled trials, which together evaluated Stiolto Respimat in more than 6,700 COPD patients. Data from OTEMTO® 1&2 were recently published online in the journal Respiratory Medicine.
Source: Boehringer Ingelheim
Filed Under: Drug Discovery