Nasal spray approved for dry eye disease
The FDA approved Tyrvaya (varenicline solution) nasal spray for the treatment of signs and symptoms of dry eye disease. Tyrvaya stimulates natural tear film production by activating the trigeminal parasympathetic pathway in the nasal cavity. Recommended dosing for Tyrvaya is one spray in each nostril twice daily.
The approval of Tyrvaya was based on data from three clinical trials, which included over 1,000 patients with mild, moderate, or severe symptoms of dry eye disease. The trials showed that treatment with Tyrvaya demonstrated statistically significant improvements in measures of natural tear film production compared with controls.
The most common adverse reaction reported in clinical trials in patients treated with Tyrvaya was sneezing.
Tyrvaya is a product of Oyster Point Pharma and is expected to be available immediately.
Asthma drug indication expanded to include younger patients
The FDA has expanded the approval of Dupixent (dupilumab) to include add-on maintenance treatment of patients 6 to 11 years of age with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Previously, treatment with Dupixent was approved only for patients 12 years of age and older. Dupixent is the only biologic medication approved for children with oral corticosteroid-dependent asthma.
The expanded approval was based on data from a phase 3 trial that evaluated the efficacy and safety of Dupixent combined with standard-of-care asthma therapy in children with uncontrolled moderate-to-severe asthma. Dupixent substantially reduced the rate of severe asthma attacks, with a 65% average reduction over 1 year compared with placebo and improved lung function in as early as 2 weeks and sustained for up to 1 year. There was improved asthma control at 24 weeks, with 81% of patients reporting a clinically meaningful improvement based on disease symptoms and impact.
Dupixent is a product of Regeneron and Sanofi. It is available as subcutaneous injection and is supplied as a prefilled syringe; a prefilled pen is available for adolescents and adults.
Update to pneumococcal vaccination guidelines recommended by CDC panel
The CDC's ACIP voted in favor of updates to the pneumococcal vaccination recommendations for two groups:
* Adults 65 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine.
* Adults 19 to 64 with certain underlying conditions (for example, diabetes, chronic heart disease, chronic lung disease, chronic liver disease, HIV) or other disease risk factors (including smoking or alcohol use disorder) who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine.
Vaccination with a pneumococcal conjugate vaccine is recommended, either 20-valent (PCV20; Prevnar 20) or 15-valent (PCV15; Vaxneuvance). If PCV15 is used, it should be followed by a dose of Pneumovax 23 (23-valent polysaccharide vaccine [PPSV23]).
These recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services.
The CDC's final recommendations will be published in the Morbidity and Mortality Weekly Report.