Respiratory

Coherus’ Cimerli has been approved to be interchangeable for all five indications, including age-related macular degeneration and diabetic retinopathy. It will be available in early October 2022.

Two studies conducted by AllianceRx Walgreens Prime call attention to the importance of adherence for reducing risk of negative health outcomes and financial costs.

Tyvaso DPI is a dry inhalation powder and new inhalation device to treat patients with pulmonary arterial hypertension, a life-threatening disease. It is expected to be available in June 2022.

Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.

The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.

The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.

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

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

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.

New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.

The anticholinergic drug tiotropium is more effective than the ?2-agonist salmeterol in preventing exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease, according to a multicenter European study published in the New England Journal of Medicine.

New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia

Agents in late-stage development for the treatment of cystic fibrosis.

This article reviews the similarities and differences between albuterol (ALB) and levalbuterol (LEV) to provide P&T committees a concise summary of the available literature regarding efficacy, side effects, and cost of these agents.

New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD

Agents in late-stage development for the treatment of asthma, COPD, and PAH

An observational retrospective study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that mortality is reduced when patients with chronic obstructive pulmonary disease (COPD) are treated with cardioselective beta-blockers before major vascular surgery.

In the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, tiotropium therapy for patients with chronic obstructive pulmonary disease (COPD) was associated with long-term improvements in lung function, quality of life, and COPD exacerbations. The therapy did not, however, significantly reduce the rate of decline in forced expiratory volume in 1 second (FEV1) compared with placebo.

A nested case-control analysis published in the Annals of Internal Medicine demonstrated an increased risk of all-cause and cardiovascular mortality among patients with recently diagnosed chronic obstructive pulmonary disease (COPD) treated with ipratropium.

Hospital-acquired pneumonia (HAP) is a frequently occurring complication of endotracheal intubation and hospitalization that is associated with a significant increase in morbidity, mortality, and cost of care.

In a retrospective cohort study of 162 primary care practices in the United Kingdom, the use of antibiotics was demonstrated to be effective in preventing serious complications following upper respiratory tract infection (URTI), sore throat, or otitis media; however, the authors stated that the number needed to treat (NNT) to prevent 1 such complication is too high to justify prescription of the drugs for this purpose.

A review of agents in late-stage development for the treatment of asthma (July 2007).

In a large, nested cohort study, use of inhaled corticosteroids at doses greater than 1,200 mcg/d was associated with a 61% reduction in the risk of developing lung cancer in patients with chronic obstructive pulmonary disease.

In a meta-analysis, inhaled corticosteroids were associated with a risk of oropharyngeal adverse events.

Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.