Respiratory Conditions

Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.

Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.

If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

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.

In high-deductible plans, patients had the highest out-of-pockets costs and abandoned and discontinued therapy at greater rates than other benefit designs.

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.

The composition of the microbiota of the airways of people with chronic obstructive pulmonary disorder explains varying degrees of inflammation, according to a review article published recently in the Annals of Medicine.

University of Buffalo researchers found that men with low incomes were at greater risk of hospital readmission.

The traditional dividing line between transmission by droplets and smaller aerosols is incorrect, say the authors of a Annals of Internal Medicine review paper, and infection control measures need to reflect the new understanding that respiratory viruses spread in respiratory particles of all sizes and perhaps mainly in aerosols.

Long-term exposure to particulate matter ≤2.5 μm (PM2.5) is associated with increased admission to the hospital for COVID-19.

An understanding of hemoglobin levels in patients with COPD could help guide disease management.

Recently approved for children 6 to 11 years, Dupixent reduces severe asthma attacks and improves lung function.

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.

In a study conducted by JAMA, results were recently released sharing children with active asthma had reduced symptom days, but not significantly, in the use of a school-wide integrated pest management program or a high-efficiency particulate air filter purifier in recorded 2-week time periods.

Efforts are underway to accelerate the development of a novel therapy for excessive airway mucus and inflammation treatment for patients with chronic obstructive pulmonary disease and non-cystic fibrosis bronchiectasis.

Three experts say that pulmonary rehabilitation programs don’t necessarily result in improved lung function but are associated with improved physical and other sorts of functioning. Less than 5% of those who might benefit from pulmonary rehabilitation services received them.

Tezepelumab, which is being currently reviewed by the FDA, provides small improvements in daily symptoms and quality of life but is only modestly cost-effectiveness at the anticipated price, according to the cost-effectiveness group's calculations.

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.