Respiratory Conditions

Investigators found patients with COPD taking Anoro Ellipta had low overall on-treatment exacerbation rates, which can reduce medical costs due to increased adherence to therapy.

The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.

Regulatory actions for drugs for children, a combination cancer therapy, launches of two generic therapies for COPD, and cancer and Alzheimer’s therapies receive Breakthrough Designation round out this week’s FDA news.

With more than 50 million Americans suffering from allergies each year, it’s critical for primary care physicians to play a pivotal role in appropriately managing asthma and allergic diseases.

The COPD Foundation is calling for a change in clinical trial design that would test experimental therapies in subsets of patients.

The first respiratory biologic to be approved for administration via an autoinjector will be available in the US soon.

FDA approved the first generic of a popular inhaler to treat asthma and chronic obstructive pulmonary disease

Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.

Pete Mulliner, an IPF patient and ambassador for the Pulmonary Fibrosis Foundation, discusses how he believes physicians should treat patients who have been recently diagnosed with IPF.

Boehringer Ingelheim recently began a clinical trial to assess the safety and tolerability of adding on pirfenidone to Ofev (nintedanib) for idiopathic pulmonary fibrosis patients.

The Pulmonary Fibrosis Foundation and Boehringer Ingelheim’s new five-year partnership, aims to raise awareness of pulmonary fibrosis, provide disease education and advance care and funding research for the PF community

Most idiopathic pulmonary fibrosis patients have considerably impaired lung function and gastroesophageal reflux disease is the most common co-morbidity, according to initial results from the IPF-PRO Registry.

A new survey of over 400 pulmonologists from 10 countries found that 88% of pulmonologists believe a delay in the diagnosis of idiopathic pulmonary fibrosis negatively impacts patients.

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.