Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, will speak about the future of drug development in pulmonary fibrosis during the PFF Summit 2015: From Bench to Bedside conference, November 12-14 in Washington D.C.
FDA approved the dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) and the stand-alone monotherapy Seebri Neohaler (glycopyrrolate) – which is one component of Utibron Neohaler -- for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
When two new treatments for idiopathic pulmonary fibrosis (IPF) were approved by FDA last year, there was not much data available on the drugs in patient populations.
Here are 3 major concerns patients with IPF should be aware of, according to research from Carlo Vancheri that appeared in a recent issue of Sarcoidosis Vasculitis and Diffuse Lung Diseases.
Pulmonary fibrosis (PF) organizations and healthcare providers are lauding the update of the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis, which was last updated in 2011.
Healthcare providers, celebrities, patients and others are helping to increase awareness of idiopathic pulmonary fibrosis (IPF) during the Pulmonary Fibrosis Foundation’s (PFF) Pulmonary Fibrosis Awareness Month.
FDA approvals for the first week of June 2015.
FDA approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat, Boehringer Ingelheim) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Because lung function can be substantially reduced by the time most chronic obstructive pulmonary disease (COPD) patients first see a physician, maintenance treatment should be considered at the time of diagnosis, according to new data analyses presented at the American Thoracic Society (ATS) 2015 International Conference.
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.
