Respiratory Conditions

In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.

FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations

Idiopathic Pulmonary Fibrosis (IPF) patients have many unmet healthcare needs and support solutions need to be implemented, according to a study published in the May, 2015 issue of the Journal of Advanced Nursing.

In a large, mutli-center study, researchers discovered potential biomarkers for accurately assessing idiopathic pulmonary fibrosis (IPF) disease progression. The study, published in the March 11 issue of The Lancet Respiratory Medicine, was led by R. Gisli Jenkins, PhD, with the Division of Respiratory Medicine at the University of Nottingham in the United Kingdom. The PROFILE study was funded by GlaxoSmithKline R & D and the Medical Research Council.

Roflumilast, a drug recently approved in the U.S. to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation – which possibly results in patients developing a tolerance to the drug after repeated use and renders it ineffective, according to a new study.

Food and Drug Administration (FDA) committees this week voted to approve GlaxoSmithKline and Theravance’s Breo ELlipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for 12 to 17-year-olds.

To address the burden of COPD on hospital expenditures, on October 1, 2014, the Centers for Medicare & Medicaid Services included COPD in its Hospital Readmissions Reductions Program. This inclusion resulted in reduced Medicare reimbursement for hospitals that demonstrate excessive 30-day COPD patient readmission rates.

Double-lung transplantation in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) was associated with better graft survival and patient survival than single-lung transplantation, according to a JAMA study.

Because there was no approved medication treatment for idiopathic pulmonary fibrosis (IPF) until mid-October, 2014, physicians primarily focused on non-pharmacological treatments to help patients improve. Even with FDA’s approval of nintedanib (Ofev) and pirfenidone (Esbriet), physicians will continue to recommend certain therapies that generally ease symptoms and improve patients’ quality of life.

While physicians laud FDA’s approval of nintedanib (Ofev) and pirfenidone (Esbriet) for treating idiopathic pulmonary fibrosis (IPF)-the first approved medications to treat the disease in the United Sates-they don’t know how to use them.

Rosuvastatin (Crestor, AstraZeneca), a cholesterol-lowering agent, is currently the most-prescribed drug among the 100 most-prescribed and best-selling drugs in the United States. In the past 12 months, new prescriptions and refills for rosuvastatin have been estimated to amount to 23.7 million.

FDA actions in brief, fast-track designations, priority review.

In patients with severe to very severe COPD and a history of exacerbation, the risk of moderate or severe exacerbations during 1 year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids (ICS) and those who discontinued ICS therapy in a step-wise manner, as long as patients continued to receive maintenance treatment with long-acting bronchodilators (tiotropium and a long-acting beta agonist [LABA]), according to data presented at the European Respiratory Society (ERS) International Congress 2014 and also published in The New England Journal of Medicine.

The Pulmonary Fibrosis Foundation (PFF) submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA). Read more about the survey data to better understand the unique needs of patients and families with IPF.

FDA actions in brief, fast-track designations, priority review, orphan drug designations

FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

FDA actions in brief, complete response, fast-track designation, priority review, orphan drug designations, first-time generic approval

Individuals with a large waist circumference may face a higher risk of developing chronic obstructive pulmonary disease (COPD), according to a study published July 7 in CMAJ (Canadian Medical Association Journal).

Pirfenidone (Esbriet), an oral antifibrotic therapy, was able to reduce progression of idiopathic pulmonary fibrosis (IPF) and reduce the risk of mortality, according to phase 3 trial results presented at the American Thoracic Society International Conference in San Diego.

The fixed-dose combination of tiotropium and olodaterol (T+O FDC) has the potential to become a viable once-daily chronic obstructive pulmonary disease (COPD) treatment, according to data presented at the 2014 American Thoracic Society (ATS) International Conference, in San Diego.

Nintedanib, an investigational small molecule tyrosine kinase inhibitor (TKI), slowed lung function loss in patients with idiopathic pulmonary fibrosis (IPF), according to the results of 2 pivotal phase 3 trials presented at the American Thoracic Society International Conference in San Diego.

Kids exposed to antibiotics in the first year of life had double the risk of developing early-onset childhood asthma, according to a study published online in Annals of Allergy, Asthma & Immunology.

FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

FDA drug approvals, breakthrough designations, fast-track designations, priority review

In an attempt to determine which patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) are at high risk for serious adverse events upon presentation to the emergency department, Canadian researchers identified 10 clinical characteristics and developed a preliminary risk scale to help standardize the admission practices of these patients.

FDA approvals, complete response, fast-track designations, priority review, first-time generic approval

FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance) once-daily for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the United States.

A new retrospective case-control study among patients with chronic obstructive pulmonary disease (COPD) found a 30% decreased risk of COPD exacerbation with any statin use.

Older patients with chronic obstructive pulmonary disease (COPD) may be at increased risk for cardiovascular events with newly prescribed long-acting beta-agonists (LABAs) and long-acting anticholinergics (LAAs) and need to be followed closely by their healthcare providers, according to a study published online May 20 for JAMA Internal Medicine.