Respiratory Conditions

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.

FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled 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 indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Humana and Boehringer Ingelheim Pharmaceuticals have announced a multi-year collaboration to address key questions regarding treatment and healthcare costs for patients with chronic obstructive pulmonary disease (COPD), cardiovascular disease, and other disease states.

Long-term treatment with fixed-combination budesonide/formoterol (Symbicort Turbuhaler, AstraZeneca) was associated with fewer healthcare utilization-defined exacerbations and hospitalizations than fluticasone/salmeterol in patients with moderate and severe chronic obstructive pulmonary disease (COPD), according to a study published online in the Journal of Internal Medicine.

Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.

Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.

Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.