FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Stiolto: New drug to treat COPD
STIOLTO RESPIMAT (tiotropium bromide and olodaterol)
(sti-OL-to– RES peh mat)
Approval date: May 21, 2015
What is the drug for?
STIOLTO RESPIMAT is a long-term treatment for adults with a lung disease called COPD (chronic obstructive pulmonary disease). It is a combination of two drugs already used for COPD.
STIOLTO RESPIMAT should only be used to treat COPD and not for other breathing problems.
Breo: New drug to treat COPD:
The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC)
The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.
Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.
“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”
Millions of smokers may have undiagnosed COPD
More than half of smokers with normal spirometry had some form of respiratory-related impairment associated with COPD, Dr. Elizabeth A. Regan and the Genetic Epidemiology of COPD (COPDGene) investigators reported in JAMA Internal Medicine.
The findings imply that up to 35 million current and former smokers older than age 55 years in the United States may have some form of respiratory-related impairment associated with COPD that has gone undiagnosed with standard spirometry, the researchers wrote (JAMA Internal Med. 2015 June 22 (doi:10.1001/jamainternmed.2015.2735).
They found that 55% of current and former smokers older than age 55 years in the study who did not meet the spirometric criteria for COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] 0 score) had significant respiratory disease. Their conclusion was based on seven metrics: chronic bronchitis (seen in 12.6% of the GOLD 0 participants), history of severe respiratory exacerbations (seen in 4.3%), dyspnea score of at least 2 (seen in 23.5%), quantitative emphysema exceeding 5% (seen in 9.8%), quantitative gas trapping exceeding 20%, (seen in 12.2%), St. George’s Respiratory Questionnaire (SGRQ) total score exceeding 25 (seen in 26%), and a 6-minute walk distance of less than 350 m (seen in 15.4%).